Recall Z-1121-2025— MICROVENTION INC.
Class II · Ongoing
Class II FDA medical device recall by MICROVENTION INC., initiated 2024-12-11. FDA's recall record names no specific 510(k) clearance for this event. 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: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer..
- Recalling firm
- MICROVENTION INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-11
- Firm location
- Aliso Viejo, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.