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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98237

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 19, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

Z-1158-2026
Recall number
Z-1158-2026
Initiated
December 19, 2025
Classification
Class I
Status
Ongoing
Quantity
557 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Code information

Material Number (UPN): M00553680; UDI-DI: 8714729951179; Lot Numbers: 35961006, , 35961007, , 35962524, , 35967379, , 35968520, 35968521, 35968597, 35968598, 35971077, 35971078, 35971079, 35972100, 35982272, 35982273, 35982274, 35982275, 35982276, 35982277, 35982278, 35982279, 35982420, 35982424, 35982425, 35985313, 35985314, 35993619, 35993720, 35993721, 36109761, 36109763, 36109764, 36109765, 36109766, 36111314, 36111315, 36118993, 36118994, 36122066, 36122067, 36122075, 36132801, 36132802, 36132803, 36132804, 36134972, 36144058, 36144059, 36144120, 36144121, 36174475, 36174476, 36178005, 36187588, 36187589, 36187687, 36187688, 36188887, 36188888, 36188889, 36194446, 36194447, 36197239, 36198580, 36217768, 36217769, 36217770, 36227341, 36227342, 36227343, 36228603, 36228604, 36228605, 36235934, 36236151, 36240589, 36240590, 36241715, 36241716, 36241717, 36251363, 36251364, 36253000, 36253008, 36253041, 36260860, 36260861, 36260862, 36261599, 36261780, 36261781, 36261834, 36261835, 36280395, 36280396, 36280397, 36281912, 36281913, 36281914, 36283860, 36292682, 36292683, 36292684, 36292689, 36292690, 36292691, 36294495, 36301621, 36301622, 36301623, 36301624, 36302290, 36302291, 36302292, 36319024, 36319025, 36319026, 36320016, 36320017, 36323789, 36323790, 36324720, 36325159, 36325560, 36325568, 36325569, 36332101, 36332102, 36341577, 36342114, 36342418, 36352008, 36352009, 36355049, 36355050, 36355752, 36359567, 36362263, 36362264, 36362265, 36363150, , 36363151, , 36364647, , 36372361, , 36372362, 36377757, 36378548, 36380549, 36388531, 36390612, 36396985, 36399492, 36403441, 36408983, 36408984, 36417820, 36417821, 36418721, 36418722, 36424650, 36424651, 36424652, 36425889, 36425890, 36425891, 36425892, 36462323, 36462324, 36469427, 36469428, 36469812, 36472250, 36472253, 36472254, 36475370, 36478478, 36478479, 36572740, 36572741, 36573582, 36573583, 36573587, 36573588, 36573589, 36573590, 36591073, 36591074, 36591075, 36603384, 36603385, 36603386, 36604188, 36604189, 36604190, 36604191, 36604748, 36604749, 36607249, 36607250, 36607251, 36607252, 36607253, 36610818, 36610819, 36611060, 36615703, 36615704, 36621589, 36621590, 36623324, 36623325, 36623326, 36693849, 36693850, 36693851, 36693852, 36694699, 36695020, 36695021, 36695023, 36698247, 36698249, 36698251, 36698527, 36698528, 36698529, 36698530, 36698531, 36698532, 36706712, 36706713, 36706714, 36706715, 36709766, 36709767, 36709768, 36709769, 36713255, 36713256, 36713257, 36713258, 36717717, 36717718, 36717719, 36717800, 36717801, 36717802, 36718966, 36718967, 36723909, 36723910, 36728154, 36764237, 36764238, 36767449, 36767450, 36771884, 36771885, 36771886, 36785593, 36788793, 36788794, 36788795, 36795369, 36795370, 36796430, 36796431, 36804013, 36804375, 36839665, 36895362, 36895363, 36895364, 36958216, 36958217, 36962750, 36970218, 36970219, 36980309, 36980310, , 36981855, , 36981856, , 36982694, , 36983909, 36985933, 36988630, 36988631, 36988632, 36990382, 36990383, 36991168, 36991170, 36991683, 36992721, 37014102, 37014103, 37014104, 37027339, 37028180, 37028181, 37030756, 37032104, 37036344, 37036345, 37037505, 37037506, 37040169, 37041012, 37041435, 37041436, 37046449, 37046450, 37046928, 37046929, 37048665, 37049464, 37049465, 37049874, 37050321, 37050322, 37050323, 37055465, 37055466, 37055467, 37056013, 37056014, 37057032, 37059006, 37059010, 37094844, 37106164, 37106583, 37131143, 37131144, 37131145, 37131146, 37177253, 37177271, 37177272, 37179955, 37179956, 37180902, 37180903, 37182323, 37183490, 37188257, 37188258, 37197563, 37197578, 37198908, 37199019, 37199360, 37199361, 37199972, 37199973, 37209169, 37209170, 37209171, 37211282, 37211285, 37212243, 37212244, 37212245, 37212246, 37213246, 37213247, 37213248, 37213249, 37240012, 37240013, 37240236, 37240237, 37240249, 37240250, 37240252, 37240254, 37242247, 37242248, 37242249, 37243754, 37243755, 37243756, 37247304, 37247305, 37247306, 37283604, 37283605, 37291851, 37291852, 37292951, 37292952, 37296017, 37296018, 37296019, 37297941, 37300544, 37300545, 37300546, 37302814, 37308038, 37308039, 37325355, 37328835, 37328836, 37328838, 37331112, 37332012, 37333358, 37333362, 37337364, 37340128, 37340129, 37340130, 37340131, 37340270, 37340271, 37341078, 37341079, 37344296, , 37344297, , 37346443, , 37346445, , 37348330, 37348331, 37352140, 37352141, 37354943, 37354944, 37357958, 37357959, 37358120, 37359884, 37359885, 37365502, 37365503, 37365504, 37365505, 37375861, 37388591, 37388592, 37388593, 37400608, 37402464, 37402466, 37410374, 37411886, 37411887, 37415923, 37415924, 37415925, 37427250, 37429329, 37429330, 37438134, 37438135, 37439609, 37439610, 37439611, 37451308, 37451309, 37454250, 37454251, 37456595, 37456596, 37459573, 37567407, 37573089, 37573090, 37573091, 37575640, 37578876, 37578877, 37578879, 37579368, 37579369, 37579370, 37582027, 37585524, 37588798, 37588799, 37589260, 37592382, 37592383, 37592384, 37596205, 37596206, 37596207, 37596208, 37601263, 37602176, 37602177, 37602178, 37602179, 37603348, 37607457, 37607458, 37607459, 37607540, 37625485, 37625486, 37626455, 37626456, 37631100, 37631101, 37633190, 37633191, 37638120, 37638121, 37638122, 37639137, 37639138, 37644407, 37644408, 37644409, 37649491, 37649492, 37686664, 37686665, 37686666, 37700937, 37700938, 37706532, 37706533, 37706534, 37708203, 37708204, 37716332, 37716333, 37718549, 37720553, 37720554, 37720555, 37727831, 37730055, 37754383, 37758168, 37758169, 37758170, 37759554, 37761362, 37761363, 37785682, 37785683, 37787089, 37787090, 37789164, 37789168, 37789169, 37820578, 37823439, 37826531, 37826532, 37832473, 37832474, 37833962, 37833963, 37834751, 37844023;

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

device · product 2 of 6

AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

Z-1159-2026
Recall number
Z-1159-2026
Initiated
December 19, 2025
Classification
Class I
Status
Ongoing
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Code information

Material Number (UPN): M00553680; UDI-DI: 191506008086; Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653, 36167912, 36241714, 36401105, 36408034, 36421237, 36447549, 36447550, 36520894, 36530482, 36530483, 36530484, 36533326, 36536257, 36536258, 36570788, 36570789, 36578110, 36581584, 36603297, 36611362, 37014108, 37429734, 37429735, 37433804, 37433805, 37440329, 37451303, 37456593, 37495326, 37511241, 37519092, 37519093, 37780825;

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

device · product 3 of 6

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

Z-1160-2026
Recall number
Z-1160-2026
Initiated
December 19, 2025
Classification
Class I
Status
Ongoing
Quantity
59 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Code information

Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043,

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

device · product 4 of 6

HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

Z-1161-2026
Recall number
Z-1161-2026
Initiated
December 19, 2025
Classification
Class I
Status
Ongoing
Quantity
266 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Code information

Material Number (UPN): M00553520; UDI-DI: 8714729904540; Lot Numbers: 36067957, 36067958, 36067959, 36067960, 36067961, 36099410, 36102139, 36111317, 36111318, 36111319, 36132439, 36132800, 36136724, 36136725, 36144054, 36154527, 36154528, 36154529, 36156019, 36164532, 36164990, 36176206, 36176207, 36177448, 36191239, 36199389, 36199390, 36217761, 36241713, 36251361, 36252913, 36271441, 36271442, 36281910, 36281911, 36292639, 36292680, 36292681, 36293836, 36300838, 36317858, 36317859, 36318240, 36323786, 36323787, 36331036, 36331037, 36331038, 36331039, 36397921, 36397922, 36397923, 36421238, 36424644, 36424645, 36427248, 36446498, 36447200, 36447201, 36449569, 36449570, 36449571, 36458829, 36459567, 36459568, 36459569, 36459570, 36461959, 36462320, 36468392, 36468393, 36468394, 36502795, 36506161, 36506163, 36509326, 36520053, 36523274, 36528114, 36536932, 36536933, 36548030, 36548031, 36548850, 36548851, 36552680, 36559035, 36559036, 36567446, 36567447, 36567448, 36574150, 36581585, 36581586, 36582790, 36582791, 36585188, 36585189, 36591087, 36592499, 36592660, 36596040, 36596041, 36609818, 36609819, 36610400, 36610401, 36621583, 36621584, 36634546, 36634547, 36664793, 36673195, 36673557, 36673558, 36675688, 36675689, 36675690, 36675692, 36677844, 36677845, 36677846, 36680231, 36680232, 36683260, 36683261, 36683262, 36693971, 36693972, 36717713, 36717714, 36717715, 36717819, 36721863, 36731805, 36731806, 36738965, 36738966, 36743835, 36750922, 36750924, 36753179, 36753400, 36781577, 36781578, 36781579, 36784378, 36784379, 36788332, 36788333, 36788334, 36792650, 36799316, 36832750, 36832837, 36832838, 36833682, 36834573, 36843542, 36844231, 36846161, 36846163, 36864951, 36864952, 36865501, 36865502, 36865504, 36865553, 36868065, 36872344, 36872346, 36878419, 36884609, 36884612, 36884613, 36895367, 36895368, 36896664, 36907033, 36907249, 36907378, 36907400, 36914565, 36915206, 36915207, 36916329, 36916330, 36917403, 36917404, 36917993, 37000847, 37003365, 37423232, 37423233, 37427258, 37427259, 37427360, 37427361, 37427362, 37437936, 37438283, 37438286, 37438287, 37439978, 37440320, 37451304, 37456594, 37457216, 37457217, 37457269, 37459571, 37463623, 37463624, 37463625, 37463628, 37469756, 37469757, 37469758, 37470669, 37472148, 37475121, 37475122, 37481983, 37486079, 37518915, 37518916, 37518917, 37519094, 37532420, 37532421, 37533309, 37543372, 37558499, 37558542, 37567252, 37567253, 37567400, 37568848, 37568849, 37571930, 37685005, 37686597, 37689957, 37689958, 37698144, 37704842, 37761033, 37761034, 37775246, 37776579, 37776720, 37776721, 37780826, 37785688, 37785689, 37811064, 37817121, 37823587, 37823588, 37826529, 37826530, 37827570, 37834839, 37836866, 37836867, 37842827;

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

device · product 5 of 6

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

Z-1162-2026
Recall number
Z-1162-2026
Initiated
December 19, 2025
Classification
Class I
Status
Ongoing
Quantity
150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Code information

Material Number (UPN): M00553530; UDI-DI: 8714729904557; Lot Numbers: 35985705, 35986358, 36147098, 36147222, 36165642, 36176423, 36190575, 36191222, 36194448, 36218745, 36227778, 36227779, 36241500, 36271259, 36280398, 36293880, 36300839, 36301620, 36343103, 36343104, 36364646, 36425887, 36469811, 36471228, 36491879, 36492660, 36506029, 36510220, 36510221, 36513401, 36513402, 36513403, 36517139, 36517220, 36525208, 36525209, 36525210, 36534514, 36534518, 36536259, 36536480, 36536481, 36551000, 36551001, 36642564, 36642565, 36642756, 36645775, 36663654, 36677842, 36677843, 36682759, 36684887, 36684888, 36730665, 36730666, 36747824, 36747825, 36753898, 36753899, 36757493, 36757494, 36761827, 36766370, 36766371, 36783265, 36792467, 36792468, 36792469, 36792470, 36792471, 36799315, 36815090, 36815092, 36832774, 36833683, 36836357, 36844783, 36845422, 36846169, 36846176, 36851617, 36851792, 36853596, 36865505, 36873631, 36873632, 36873906, 36874863, 36904228, 36904229, 36904230, 36907002, 36907003, 36907004, 36907028, 37102533, 37102534, 37102535, 37102536, 37102537, 37459567, 37459568, 37459569, 37459570, 37463133, 37470670, 37498192, 37511243, 37519095, 37519096, 37844029, 37519097, 37520927, 37530320, 37530321, 37530333, 37533308, 37541933, 37571927, 37571928, 37579364, 37579366, 37579367, 37580630, 37585525, 37585526, 37589261, 37589262, 37594668, 37649481, 37649482, 37649483, 37650631, 37694052, 37699011, 37699012, 37708202, 37779125, 37779126, 37780822, 37780823, 37780824, 37823589, 37823590, 37827568, 37827569, 37833165, 37833176, 37834499;

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

device · product 6 of 6

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

Z-1163-2026
Recall number
Z-1163-2026
Initiated
December 19, 2025
Classification
Class I
Status
Ongoing
Quantity
588 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Code information

Material Number (UPN): M00553560; UDI-DI: 8714729951100; Lot Numbers: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, 36002903, 36002904, 36003946, 36003947, 36003948, 36012845, 36012846, 36012847, 36012848, 36015761, 36021049, 36021050, 36021051, 36021052, 36027054, 36027055, 36027056, 36027057, 36027058, 36027059, 36027060, 36027061, 36038410, 36038411, 36040000, 36040001, 36040002, 36040003, 36040004, 36048795, 36048796, 36048797, 36048798, 36049282, 36049283, 36049284, 36050387, 36050388, 36050389, 36059222, 36059223, 36059224, 36059225, 36062077, 36062078, 36062079, 36064449, 36065116, 36065117, 36067962, 36067963, 36067964, 36069958, 36069959, 36070600, 36070608, 36070609, 36070610, 36070611, 36072736, 36072737, 36092333, 36092334, 36092335, 36099411, 36099412, 36099413, 36101743, 36101744, 36101745, 36101746, 36101747, 36102812, 36102813, 36102814, 36135590, 36135591, 36144122, 36144123, 36147096, 36147097, 36154534, 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Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

Field note

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