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 catalogue number |
|---|---|---|
| Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System | More than 10 numbers, contact manufacturer. | M00553520 |
| Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System | More than 10 numbers, contact manufacturer. | M00553530 |
| Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System | More than 10 numbers, contact manufacturer. | M00553560 |
Issue
Boston Scientific is initiating a removal of certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm). This action is being taken due to increased reports of stent deployment and expansion issues with these configurations. This issue only occurs at the time of delivery of the stent and is expected to be noticed by the physician. Successfully implanted stents are not affected by this issue.
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 I
Recall date
Identification number
RA-81391
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