Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MicoVention Terumo Recalled by MICROVENTION INC. Due to Potential for Polytetrafluoethylene (PTFE) material encasing the stent...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MICROVENTION INC. directly.
Affected Products
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.
Quantity: 11 units
Why Was This Recalled?
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Where Was This Sold?
US: None OUS: China
About MICROVENTION INC.
MICROVENTION INC. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report