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Terminated

ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.

FDA Recall Z-1816-2008 · Posted 2008-09-21

Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeNIP
Date Initiated2008-04-09
Date Terminated2009-05-27
Product Quantity1

Reason for Recall

An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.

Firm Action

ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested.

Root Cause

Labeling mix-ups

Distribution Pattern

CA

Official Source

View FDA Recall →

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

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