Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - 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 8 units of the Hot AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm) with lot number 26130517 and expiration date of 10/5/2022. 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 result in delays to the procedure or create a risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity. The affected units were distributed nationwide in the US. The source document does not specify a remedy or required 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: 8 units Lot/code info: Lot Number: 26130517 Exp. Date Range: 10/5/2022 GTIN: 08714729904564
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.