Class 2 Device Recall Medtronic

• Date Initiated by Firm: November 01, 2006
• Date Posted: November 22, 2006
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-0208-2007
• Recall Event ID: 36845
• 510(K)Number: K031920
• Product Classification: vascular catheter - Product Code ITX
• Product: Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
• Code Information: All Codes.
• FEI Number: 3003311129
• Recalling Firm/ Manufacturer: Medtronic Vascular; 5345 Skylane Boulevard; Santa Rosa CA 95403-1044
• For Additional Information Contact: Angela Tucker; 707-591-2658
• Manufacturer Reason for Recall: Sterility may be compromised as evidenced by a loss of package integrity.
• FDA Determined Cause: Other
• Action: On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
• Quantity in Commerce: 502
• Distribution: Worldwide, including USA, Switzerland, France, Belgium, Germany.
• 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 = ITX