Recall MonitorHealth ProductsType I recall
Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
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
Recall class: Type I
Products
| Affected products | Model or catalogue number | Lot or serial number |
|---|---|---|
| Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System | M00553560 | More than 10 numbers, contact manufacturer. |
| Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System | M00553520 | More than 10 numbers, contact manufacturer. |
| Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System | M00553530 | More than 10 numbers, contact manufacturer. |
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.