Z-0774-2021 Class II Terminated
FDA device recall Z-0774-2021 was initiated by Boston Scientific Corporation on December 1, 2020 and is designated Class II. Reason for recall: 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 pr… The recall status is terminated (terminated July 14, 2023). Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- December 1, 2020
- Termination Date
- July 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - 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 for Recall
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
Distribution Pattern
US Nationwide distribution - Foreign: TBD.
Code Information
Lot Number: 26152465, 26152466, 26152467 Exp. Date: 10/8/2022 GTIN: 08714729904595