AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - 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 38 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm, UPN M00553660) distributed nationwide in the US. The recall involves three specific lot numbers (26167271, 26152176, 26167274) with expiration dates between October 8-12, 2021. The stent is designed for implantation up to 60 days.
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 cause a delay in the procedure or result in peritonitis, a serious infection caused by leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity. The source document does not specify what actions 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: 38 units Lot/code info: Lot Number: 26167271, 26152176,26167274 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951179
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.