HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, 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: FDA Class II device recall with a functional malfunction that directly prevents proper stent expansion and requires procedure extension and device replacement. No patient injuries or hospitalizations have been reported.
Plain-English summary
Boston Scientific Corporation is recalling the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mmx8mm (UPN: M00553530). This is a medical device used in endoscopic procedures to place stents. A total of 91 units distributed outside the United States are affected, with specific lot numbers identified.
The outer sheath of the device has been reported to detach at the distal black tip. When this occurs, the detached portion can remain around the stent saddle, preventing the stent from expanding properly during the procedure.
When the outer sheath detaches, the procedure must be extended, and the device must be exchanged for a new one. The recall was initiated in response to reports of this defect. Healthcare providers using affected lot numbers should contact Boston Scientific for further guidance.
The recalled product
- Product
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
- 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 (8)
- GTIN: 08714729904557 Lot Numbers: 33335139
- 33335340
- 33336413
- 33511491
- 34015885
- 34065661
- 34068983
- 34101926
Distribution
Distributed nationwide across the United States.
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