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Terminated

ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter

FDA Recall Z-1489-2014 · Posted 2014-04-23

Recalling FirmEv3, Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2014-04-09
Date Terminated2014-10-06
Product Quantity39 units (31 OUS, 8 US)

Reason for Recall

Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.

Firm Action

Consignees were sent a Covidien "Urgent Product Recall" letter dated April 09, 2014. The letter described the problem and the product involved in the recall. The letter described the required actions which included to immediately quarantine and discontinue use of the affected devices and to return affected product. Requested consignees to complete the Verification Form and return it to their Covidien Sales Representative. For questions they can contact Covidien Customer Service at 1-800-716-6000.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103322EVERCROSS 0.035 OTW PTA DILATION CATHETEREv3, Inc. · 2010-12-06K082579EVERCROSS .035 OTW PTA DILATATION CATHETEREv3, Inc. · 2008-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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