AXIOS Stent Distal Tip Detachment Prevents Proper Expansion
Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a functional defect that prevents proper stent expansion and requires device exchange during the procedure. While no patient injuries have been reported, this represents a risk of treatment failure and procedural complications from incomplete stent placement.
Plain-English summary
Boston Scientific Corporation is recalling AXIOS Stent and Electrocautery-Enhanced Delivery System devices (6mm x 8mm, UPN M00553680) due to a reported defect where the outer sheath distal black tip can detach from the device during use.
When the distal tip detaches, it can remain around the stent saddle, preventing proper stent expansion. This malfunction requires the healthcare provider to stop the procedure and exchange the defective device for a new one, prolonging the procedure time.
The recall affects 31 units with lot numbers 33457806, 33512838, and 34035520, distributed nationwide including Puerto Rico. Healthcare facilities using these devices should stop use of affected lots and contact Boston Scientific for instructions on device replacement or further guidance.
The recalled product
- Product
- AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
- Manufacturer
- Boston Scientific Corporation
- Hazard
- component-detachment
- stent-expansion-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN: 00191506008086 Lot Numbers: 33457806
- 33512838
- 34035520
Distribution
Distributed nationwide across the United States.
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