CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
MicoVention Terumo, LVIS Intraluminal Support Device recalled
Microvention is recalling MicoVention Terumo, LVIS Intraluminal Support Device. The recall was initiated on 11 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1121-2025
- FDA event ID
- 96114
- Recalling firm
- Microvention, Aliso Viejo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2024
- FDA classified
- 7 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Dec 2024 | Recall initiated by company | |
| 7 Feb 2025 | Classified by FDA | +58 days |
| 19 Feb 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Product as listed by the FDA
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.
Where it was distributed
US: None OUS: China
Questions about this recall
Why was it recalled?
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Which lots are affected?
Lot number: 0000456768
Where was it sold?
US: None OUS: China
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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