Class 2 Device Recall Medtronic

• Date Initiated by Firm: September 15, 2004
• Date Posted: September 29, 2004
• Recall Status: Terminated on November 03, 2005
• Recall Number: Z-1489-04
• Recall Event ID: 30016
• 510(K)Number: K845045 K891687
• Product Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
• Product: Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
• Code Information: Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
• Recalling Firm/ Manufacturer: Medtronic Inc; 710 Medtronic Pkwy; Minneapolis MN 55432-5603
• Manufacturer Reason for Recall: Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
• FDA Determined Cause: Other
• Action: A notification letter dated September 23, 2004 was sent by certified mail to US customers. The letter cautions the customer about the possibility of tip detachment and requests the impacted product to be returned to Medtronic for replacement. Customers are requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.
• Quantity in Commerce: 753 units, 203 distributed in US to 24 customers.
• Distribution: Nationwide throughout the United States and worldwide.
• 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; 510(K)s with Product Code = DWF