HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Reported: February 5, 2025 Initiated: December 20, 2024 #Z-1036-2025
Product Description
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
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
- 1102 units (OUS)
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560. Recalled by Boston Scientific Corporation. Units affected: 1102 units (OUS).
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-1036-2025.
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