CanadaThe Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System by Boston Scientific (models M00553520, M00553530, M00553560; configurations 6×8 mm, 8×8 mm, and 20×10 mm) is being removed. The action was taken because of increased reports of stent deployment and expansion issues occurring at the time of delivery, which the physician is expected to notice; successfully implanted stents are not affected. Contact the manufacturer for additional information.
What's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00553520
Affected products: Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00553530
Affected products: Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00553560
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States