Recall Z-1036-2025— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-12-20. It names one FDA 510(k) clearance: K233318. Product: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560. Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-20
- Firm location
- Marlborough, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.