FDA recall Z-1027-2025

Boston Scientific Corporation · Class II · device

Product

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

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.

Distribution

Nationwide including Puerto Rico Foreign: To be provided

Key facts

Status: Ongoing
Initiation date: 2024-12-20
Report date: 2025-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1027-2025