AXIOS Stent Delivery System Outer Sheath Detachment Recall (47 Units)
Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.
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 recall for a medical device with a documented mechanical defect (outer sheath detachment) that prevents proper stent expansion. No illnesses or injuries have been reported. The defect creates a risk of inadequate treatment outcome, meeting the criteria for a High severity score as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling its AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm (UPN: M00553690). The recall affects 47 units distributed nationwide, including Puerto Rico. The affected lot numbers are 33419782, 33477824, 34116467, 33419783, and 33511487. This is a Class II recall.
The outer sheath distal black tip can detach from the device and remain lodged around the stent saddle. When the sheath detaches, it prevents proper stent expansion, resulting in prolongation of the procedure. The healthcare provider must exchange the affected device for a new one to complete the procedure.
The recalled product
- Product
- AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
- Manufacturer
- Boston Scientific Corporation
- Hazard
- sheath-detachment
- stent-expansion-failure
- device-malfunction
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 (5)
- GTIN: 00191506008093 Lot Numbers: 33419782
- 33477824
- 34116467
- 33419783
- 33511487
Distribution
Distributed nationwide across the United States.
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