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MICROVENTION INC. recalls MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297
Recalled February 19, 2025 · FDA recall Z-1121-2025 · MICROVENTION
Hazard
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer. · FDA Class II
Units
11 units
Sold at
US: None OUS: China
Description
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
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.
Manufacturer(s)
MICROVENTION INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →