AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Reported: February 5, 2025 Initiated: December 20, 2024 #Z-1029-2025
Product Description
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
Reason for Recall
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 47 units
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690. Recalled by Boston Scientific Corporation. Units affected: 47 units.
Why was this product recalled? ▼
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2025. Severity: Moderate. Recall number: Z-1029-2025.
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