Class 2 Device Recall EverCross 0.035" OTW PTA Dilatation Catheter

• Date Initiated by Firm: April 09, 2014
• Date Posted: April 23, 2014
• Recall Status: Terminated on October 06, 2014
• Recall Number: Z-1489-2014
• Recall Event ID: 68034
• 510(K)Number: K082579 K103322
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: 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
• Code Information: AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16
• Recalling Firm/ Manufacturer: Ev3, Inc.; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: Covidien Customer Service; 800-716-6000
• Manufacturer 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.
• FDA Determined Cause: Labeling Change Control
• 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.
• Quantity in Commerce: 39 units (31 OUS, 8 US)
• Distribution: 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.
• 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.

• 510(K) Database: 510(K)s with Product Code = DQY; 510(K)s with Product Code = DQY