Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - 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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling the AXIOS Stent with Electrocautery-Enhanced Delivery System (10mm x 15mm) distributed nationwide in the United States. The recall affects 61 units across five specific lot numbers (26156059, 26167275, 26167276, 26156742, and 26156740) with expiration dates in October 2022. The issue involves a rotating luer fitting at the distal end of the delivery system handle that may become detached during device preparation, stent delivery, or use.
The detachment of this fitting could result in delayed procedures or serious complications including peritonitis, which can occur if enteric, pseudocyst, or biliary contents leak into the peritoneal cavity. The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: US Nationwide distribution - Foreign: TBD. Quantity: 61 units Lot/code info: Lot Number: 26156059, 26167275, 26167276, 26156742, 26156740 Exp Date: 10/9/2022 10/12/2022 GTIN: 08714729904571
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.