FDA recall Z-1121-2025

MICROVENTION INC. · Class II · device

Product

MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

Reason for recall

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

Distribution

US: None OUS: China

Key facts

Status
Ongoing
Initiation date
2024-12-11
Report date
2025-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1121-2025