FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
- Recall number
- Z-0625-03
- Recalling firm
- Medtronic, Inc.
- Product
- Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
- Status
- Terminated
- Initiated
- 2003-01-31
- Posted
- 2003-03-06
- Terminated
- 2003-05-01
- 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
- Lot, serial or model codes
- Lot Numbers: 122851, 12852, 122853
- 510(k) numbers
- ["K942269"]
- PMA numbers
- not on file
- Product code
- LOX
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28