Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0776-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 1, 2020

Date Posted: January 13, 2021

Recall Number: Z-0776-2021

Event ID: 86909

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

Status: Terminated

Product Quantity: 8 units

Code Information:

Lot Number: 26130517 Exp. Date Range: 10/5/2022 GTIN: 08714729904564

Distribution Pattern:

US Nationwide distribution - Foreign: TBD.

Voluntary or Mandated:

Voluntary: Firm initiated