AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - 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 13 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm, UPN M00553640) from Lot Number 26134666 with an expiration date of October 6, 2022. The stent is designed for implantation up to 60 days. The recall was issued because the rotating luer fitting at the distal end of the delivery system handle may detach from the nose of the delivery during device preparation, stent delivery, or use.
If the luer fitting detaches, it could delay the procedure or create a risk of peritonitis, a serious abdominal infection caused by leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity. The recalled units were distributed nationwide in the United States, with foreign distribution status to be determined.
The recall notice does not specify 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: 13 units Lot/code info: Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.