LVIS Intraluminal Support Device May Fail to Deploy Properly
MicoVention Terumo LVIS stent devices may fail to advance from the introducer due to PTFE material on the stent loop. Eleven units (Lot 0000456768) distributed in China are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving potential device malfunction during use. This is a risk-of-harm scenario where the device may fail to deploy in a critical neurovascular procedure; however, no adverse events or injuries have been reported.
Plain-English summary
MicoVention Terumo is recalling 11 units of its LVIS Intraluminal Support Device (Lot 0000456768). The LVIS device is used as a stent-assisted coiling support device for the treatment of wide-necked aneurysms.
The recall was initiated because polytetrafluoroethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer. This could prevent the device from deploying as intended during the procedure.
The affected units were distributed only in China. No distribution occurred in the United States. Healthcare facilities and physicians with this lot number should contact MicoVention Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- MICROVENTION INC.
- Hazard
- device-malfunction
- deployment-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 0000456768
Distribution
Distribution scope not specified by the agency.
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