Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
FDA device recall Z-0625-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Medtronic, Inc.
- Reason for recall
- PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOX
- Quantity affected
- 602 units
- Distribution
- Japan
- Date initiated
- 2003-01-31
- Date posted
- 2003-03-06
- Date terminated
- 2003-05-01
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC EVEREST INFLATION DEVICE (K942269) | Medtronics Interventional Vascular | 1994-10-18 |