Recalls / —
—#25950
Product
Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
- FDA product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K942269
- Affected lot / code info
- Lot Numbers: 122851, 12852, 122853
Why it was recalled
PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Medtronic, Inc.
- Address
- 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923
Distribution
- Distribution pattern
- Japan
Timeline
- Recall initiated
- 2003-01-31
- Posted by FDA
- 2003-03-06
- Terminated
- 2003-05-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #25950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.