Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0775-2021)

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:

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.

Product Classification:

Class II

Date Initiated: December 1, 2020

Date Posted: January 13, 2021

Recall Number: Z-0775-2021

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: 38 units

Code Information:

Lot Number: 26167271, 26152176,26167274 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951179

Distribution Pattern:

US Nationwide distribution - Foreign: TBD.

Voluntary or Mandated:

Voluntary: Firm initiated