Class 3 Device Recall IntraCoil

• Date Initiated by Firm: April 09, 2008
• Date Posted: September 21, 2008
• Recall Status: Terminated on May 27, 2009
• Recall Number: Z-1816-2008
• Recall Event ID: 48102
• PMA Number: P000033
• Product Classification: peripheral vascular stent - Product Code NIP
• Product: ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
• Code Information: Lot 4401214
• Recalling Firm/ Manufacturer: Ev3, Inc; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: 763-398-7000
• Manufacturer Reason for Recall: An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
• FDA Determined Cause: Labeling mix-ups
• 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.
• Quantity in Commerce: 1
• Distribution: CA
• 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