Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
Brand(s)
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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