medical MODERATE Updated 2025-02-19

MICROVENTION INC. recalls MicoVention Terumo, LVIS Intraluminal Support Device, REF: 2

See all recalls from MICROVENTION INC. →

Recalled 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 wide-necked aneurysms.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

Issued by

FDA

Distribution: US: None OUS: China
Lot/Code Info: Lot number: 0000456768

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for MicoVention Terumo, LVIS Intraluminal →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Rystem, Model Numbers: 722063, 722064, 722

2026-08-19 · Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code:

2026-08-19 · Due to increase in false negative results

OBP Medical Corporation recalls OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED L

2026-08-19 · There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

Covidien, LP recalls Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 888617

2026-08-19 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.