MICROVENTION INC.: Device Recall

Recall Details

Recall Number

Z-1121-2025

Classification

Class II

Product Type

Device

Recalling Firm

MICROVENTION INC.

Status

Ongoing

Date Initiated

12/11/2024

Location

Aliso Viejo, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

11 units

Reason for Recall

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

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.

Distribution Pattern

US: None OUS: China

Other Recalls by MICROVENTION INC.

• Class II: Risk 09/05/2025
  Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
• Class II: Risk 05/29/2025
  Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
• Class II: Risk 12/02/2024
  Sterility assurance; microcatheter inner packaging may contain incomplete seal.
• Class II: Risk 08/05/2024
  Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.

View all recalls by MICROVENTION INC. →