Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - 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 78 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm, for outside US markets) due to a defect in the rotating luer fitting at the distal end of the delivery system handle. The fitting may become detached during device preparation, stent delivery, or use, which could delay the procedure or allow enteric, pseudocyst, or biliary contents to leak into the peritoneal cavity and cause peritonitis. The recall affects six specific lot numbers with expiration dates ranging from October 8, 2021 to October 12, 2021, and has been distributed nationwide in the US.
The recalled product was intended for stent implantation up to 60 days. The recall notice does not specify a remedy or recommended action for affected consumers.
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: 78 units Lot/code info: Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.