MICROVENTION INC.: Medical Device Recall in 2025 - (Recall #: Z-1121-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 11, 2024

Date Posted: February 19, 2025

Recall Number: Z-1121-2025

Event ID: 96114

Reason for Recall:

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

Status: Ongoing

Product Quantity: 11 units

Code Information:

Lot number: 0000456768

Distribution Pattern:

US: None OUS: China

Voluntary or Mandated:

Voluntary: Firm initiated