MICROVENTION INC. 2026-05-20 Health serious FDA
Health · FDA · Recall #FDA-Z-2200-2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking… Recall
Issued May 20, 2026 · MICROVENTION INC.
In May 2026, MICROVENTION INC. recalled the LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact MICROVENTION INC. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- MICROVENTION INC.
- Category
- Health
- Recall date
- May 20, 2026
- Units affected
- Not reported
- Sold at
- International distribution to the country of China.
- Recall number
- FDA-Z-2200-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- MICROVENTION INC. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.