Microvention Inc.: Intracranial Coil-assist Stent
Recall Summary MicroVention is recalling specific batches of LVIS Intraluminal Support Devices (stent-assist coils used in brain procedures) because some units may be the wrong size or incorrectly assembled due to manufacturing issues. These dimensional problems could cause either vessel damage if the device is too large or blood clots and stroke if the device is too small. The affected products were distributed internationally, including to China.
- Recalling firm
- MICROVENTION INC.
- Product
- LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
- Reason
- Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-06
- Status
- Open, Classified
- Distribution
- International distribution to the country of China.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/aa3686e6-3c6c-477d-9b79-a630fd073eed