Exact FDA event identifier

Event 68834

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

Event summary

Timeline bucket: June 23, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cordis 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

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

Cordis EMPIRA NC RX PTCA Dilatation Catheter

Z-2556-2014

Recall number: Z-2556-2014
Initiated: June 23, 2014
Classification: Class II
Status: Terminated
Recalling firm: Cordis Corporation
Quantity: 250,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Environmental control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.

Code information

63 Catalog numbers: 75R06200N, 75R06225N, 75R06250N, 75R06275N, 75R06300N, 75R06325N, 75R06350N, 75R06375N, 75R06400N, 75R10200N, 75R10225N, 75R10250N, 75R10275N, 75R10300N, 75R10325N, 75R10350N, 75R10375N, 75R10400N, 75R12200N, 75R12225N, 75R12250N, 75R12275N, 75R12300N, 75R12325N, 75R12350N, 75R12375N, 75R12400N, 75R15200N, 75R15225N, 75R15250N, 75R15275N, 75R15300N, 75R15325N, 75R15350N, 75R15375N, 75R15400N, 75R20200N, 75R20225N, 75R20250N, 75R20275N, 75R20300N, 75R20325N, 75R20350N, 75R20375N, 75R20400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, 75R25400N, 75R25200N, 75R25225N, 75R25250N, 75R25275N, 75R25300N, 75R25325N, 75R25350N, 75R25375N, and 75R25400N.

Distribution pattern

Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.

device · product 2 of 2

Cordis EMPIRA RX PTCA Dilatation Catheter

Z-2557-2014

Recall number: Z-2557-2014
Initiated: June 23, 2014
Classification: Class II
Status: Terminated
Recalling firm: Cordis Corporation
Quantity: 250,000 units.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Environmental control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S, 85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S 85R30325S, 85R30350S, 85R30375S, and 85R30400S.