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Terminated

ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The IntaCoil stent is indicated for placement in flexing regions and a tortuous lesion.

FDA Recall Z-1815-2008 · Posted 2008-09-11

Recalling FirmEv3, Inc
Recall StatusTerminated
Product CodeNIP
Date Initiated2008-04-02
Date Terminated2011-12-10
Product Quantity3

Reason for Recall

Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135).

Firm Action

ev3 representative retrieved from the consignnee the affected device on 4/4/08. A Device Reconcilliation Form was requested to be filled and returned with the product.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution including states of CA and MO.

Official Source

View FDA Recall →

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

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