AXIOS Stent Delivery System recalled due to distal sheath detachment
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
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: This is a Class II medical device recall with no reported illnesses or injuries in the source. The hazard is device malfunction (component detachment preventing proper stent expansion). Per the rubric, recalls without reported adverse outcomes are at most Score 3.
Plain-English summary
Boston Scientific Corporation is recalling 38 units of the AXIOS Stent and Delivery System (15mmx10mm, UPN: M00553750) in a Class II recall due to a potential defect affecting device functionality.
The outer sheath's distal black tip may detach from the device during use. When detachment occurs, the tip can remain around the stent saddle, preventing the stent from expanding properly.
If a stent fails to expand as intended, the medical procedure must be prolonged and the device must be exchanged for a new one. The affected units are identified by lot numbers 33740402, 33785754, and 34037422. The recall applies to products distributed nationwide, including Puerto Rico.
The recalled product
- Product
- AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- 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: 08714729904632 Lot Numbers: 33740402
- 33785754
- 34037422
Distribution
Distributed nationwide across the United States.
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