FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
- Recall number
- Z-2350-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
- Status
- Open, Classified
- Initiated
- 2024-06-12
- Posted
- 2024-07-12
- Terminated
- not on file
- Reason
- Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
- Root cause
- Process control
- Action
- All customers notified via courier on June 12, 2024 - notice was titled "Urgent Medical Device Removal." Customers were informed to cease further use or distribution of any remaining affected product. Product should be segregated and returned to the firm. For more information, please reach out to your local Boston Scientific representative.
- Quantity
- 256 US, 39 OUS
- Distribution
- Domestic distribution nationwide.
- Lot, serial or model codes
- UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
- 510(k) numbers
- ["K013153"]
- PMA numbers
- not on file
- Product code
- KNS
- 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