Exact FDA event identifier

Event 93615

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

Event summary

Timeline bucket: December 01, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Maquet Cardiovascular, LLC

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

2 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 2

Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .

Z-0723-2024

Recall number: Z-0723-2024
Initiated: December 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Maquet Cardiovascular, LLC
Quantity: 554 units (OUS)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.

Code information

UDI-DI: 00607567700413, Lots: 3000283735, 3000293031, 3000310304, 3000333956.

Distribution pattern

US: OUS: China, Brazil, Hong Kong.

device · product 2 of 2

Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.

Z-0724-2024

Recall number: Z-0724-2024
Initiated: December 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Maquet Cardiovascular, LLC
Quantity: 38,094 units (US)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

UDI-DI: 00607567701250, Lots: 3000279266, 3000280189, 3000281082, 3000281083, 3000281381, 3000282927, 3000283156, 3000281741, 3000286706, 3000287254, 3000288363, 3000288576, 3000289020, 3000289548, 3000289927, 3000290482, 3000291429, 3000291157, 3000291645, 3000292098, 3000293522, 3000293788, 3000293823, 3000295050, 3000294365, 3000295346, 3000296172, 3000296021, 3000296498, 3000297028, 3000300016, 3000299854, 3000300155, 3000300260, 3000301042, 3000301666, 3000302760, 3000303282, 3000303854, 3000304912, 3000304645, 3000306277, 3000306437, 3000307090, 3000307871, 3000308725, 3000310691, 3000311127, 3000311525, 3000311892, 3000312494, 3000312722, 3000314373, 3000314821, 3000316023, 3000316027, 3000316024, 3000317576, 3000317501, 3000317575, 3000318901, 3000318302, 3000320140, 3000320141, 3000320773, 3000320773, 3000321483, 3000321723, 3000323214, 3000324409, 3000324397, 3000325013, 3000325249, 3000325689, 3000325776, 3000328206, 3000328561, 3000329723, 3000328562, 3000330445, 3000331131, 3000331388, 3000332428, 3000332510, 3000332993, 3000333524, 3000333829, 3000334315, 3000335670, 3000336708, 3000337272, 3000339701, 3000340534, 3000341675, 3000341133, 3000342250, 3000342251, 3000343266, 3000343264, 3000344887, & 3000351187.

Distribution pattern

US: OUS: China, Brazil, Hong Kong.