FDA Enforcement
Class II
Terminated
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Recall: Z-0776-2021
·
Reported January 13, 2021
Enforcement
- Recall Number
- Z-0776-2021
- Event ID
- 86909
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 13, 2021
- Initiation Date
- December 1, 2020
- Classification Date
- January 6, 2021
- Termination Date
- July 14, 2023
- Address
- 300 Boston Scientific Way, Marlborough, MA, 01752-1291, United States
Description
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Reason
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Code Info
Lot Number: 26130517 Exp. Date Range: 10/5/2022 GTIN: 08714729904564
Distribution
US Nationwide distribution - Foreign: TBD.
Quantity
8 units