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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic AVE Everest PTCA Inflation Catheter 20 cc

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  Class 2 Device Recall Medtronic AVE Everest PTCA Inflation Catheter 20 cc see related information
Date Initiated by Firm January 31, 2003
Date Posted March 06, 2003
Recall Status1 Terminated 3 on May 01, 2003
Recall Number Z-0625-03
Recall Event ID 25514
510(K)Number K942269  
Product Classification Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
Product Medtronic AVE Everest PTCA Inflation Catheter 20 cc
Item #AC2200
Code Information Lot Numbers: 122851, 12852, 122853
Recalling Firm/
Manufacturer		 Medtronic, Inc.
35-37A Cherry Hill Drive
Danvers MA 01923
For Additional Information Contact Fred L. Boucher
978-739-3116
Manufacturer Reason
for Recall		 PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon
FDA Determined
Cause 2		 Other
Action Medtronic AVE notified the two distributors in Japan on 1/31/2003 who will notify the sales representative to retrieve product from the hospital accounts.Product will be returned to Danvers, accounted and scrapped.
Quantity in Commerce 602 units
Distribution Japan
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 = LOX and Original Applicant = MEDTRONICS INTERVENTIONAL VASCULAR
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