Class 3 Device Recall IntraCoil Peripheral Stent Vascular

• Date Initiated by Firm: April 02, 2008
• Date Posted: September 11, 2008
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-1815-2008
• Recall Event ID: 48098
• PMA Number: P000033
• Product Classification: Superficial femoral artery stent - Product Code NIP
• Product: 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.
• Code Information: Lot No: 4401432
• Recalling Firm/ Manufacturer: Ev3, Inc; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: 763-398-7000
• Manufacturer 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).
• FDA Determined Cause: Employee error
• 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.
• Quantity in Commerce: 3
• Distribution: Nationwide Distribution including states of CA and MO.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NIP