Recall Z-1028-2025— Boston Scientific Corporation

Name: FDA recall Z-1028-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-20

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: AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680. 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 record

K233318 — AXIOS Stent and Electrocautery-Enhanced Delivery System (6 models)Boston Scientific Corporation·cleared 2023-10-27

K-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

AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

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.