Recall Z-0625-03 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Medtronic, Inc.
Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
| Date | Mar 6, 2003 (initiated Jan 31, 2003) |
| Status | Terminated |
| Reason | PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon |
| Root cause | 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 | 602 units |
| Distribution | Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942269 | MEDTRONIC EVEREST INFLATION DEVICE Medtronics Interventional Vascular, Oct 18, 1994 |