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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 32 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 15mm, UPN M00553650) distributed nationwide in the US. The recalled stent is intended for implantation up to 60 days and is identified by lot numbers 26152465, 26152466, or 26152467, with an expiration date of October 8, 2022.
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. This detachment could delay the procedure or result in leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity, potentially causing peritonitis. The source document does not specify what action affected consumers should take.
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: 32 units Lot/code info: Lot Number: 26152465, 26152466, 26152467 Exp. Date: 10/8/2022 GTIN: 08714729904595
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.