Health product recall

Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

Last updated

Summary

Product
Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System

More than 10 numbers, contact manufacturer.

M00553520
M00553570
M00553550
M00553530
M00553540
M00553560

Issue

Boston Scientific is initiating a removal of specific lots of the AXIOS™ Stent and Electrocautery Enhanced Delivery System due to reports of the outer sheath distal black tip detaching from the device. Boston Scientific has received seven (7) reports of this issue between June 1, 2023, and present day.

Recall start date: December 20, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Boston Scientific Corporation

300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76806

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