Class 2 Device Recall Medtronic EOPA Arterial Cannula

• Date Initiated by Firm: July 24, 2015
• Date Posted: August 19, 2015
• Recall Status: Terminated on April 04, 2016
• Recall Number: Z-2420-2015
• Recall Event ID: 71897
• 510(K)Number: K031037
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
• Code Information: Lot number 2015060544
• Recalling Firm/ Manufacturer: Medtronic Perfusion Systems; 7611 Northland Dr N; Brooklyn Park MN 55428-1088
• For Additional Information Contact: Lifeline Technical Services; 877-526-7890
• Manufacturer Reason for Recall: EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
• FDA Determined Cause: Packaging process control
• Action: On July 24, 2015 Medtronic sales representatives began verbally notifying the customers of the issue, requesting quarantine and return of un-used, affected product Consignees were sent a Medtronic "Urgent Medical device Recall" letter dated August 2015. The letter was addressed to Risk Manger and Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to quarantine and remove the product from their inventory and return it to Medtronic. Requested consignees to complete and return the Customer Confirmation Certificate via email to RS.CFQFCA@Medtronic com or fax to Medtronic 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic Sales Representative or Lifeline Technical Services at 1-877-526-7890.
• Quantity in Commerce: 221 (111 US, 110 OUS)
• Distribution: Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
• 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 = DWF