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AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usa...

FDA Recall #Z-0773-2021 — Class II — December 1, 2020

Recall #Z-0773-2021 Date: December 1, 2020 Classification: Class II Status: Terminated

Product Description

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.

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

Recalling Firm

Boston Scientific Corporation — Marlborough, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

13 units

Distribution

US Nationwide distribution - Foreign: TBD.

Code Information

Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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