FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- Recall number
- Z-2442-2019
- Recalling firm
- Boston Scientific Corporation
- Product
- AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- Status
- Terminated
- Initiated
- 2019-07-19
- Posted
- not on file
- Terminated
- 2020-04-23
- Reason
- Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
- Root cause
- Error in labeling
- Action
- Boston Scientific contacted customer via the sales representative on July 19, 2019. The removal letter was given to the customer by the sales representative. The letter states reason for recall, health risk and Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific
- Quantity
- 1 unit
- Distribution
- MN
- Lot, serial or model codes
- Lot Number: 23973023
- 510(k) numbers
- not on file
- PMA numbers
- ["P000053"]
- Product code
- EZY
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- 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