Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
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