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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm November 01, 2006
Date Posted November 22, 2006
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = TRANS VASCULAR INCORPORATED
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