Z-1121-2025Class II

MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm...

Name: Z-1121-2025 MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm...
Creator: Microvention Inc.
Published: 2024-12-11
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2024-12-11 / Open, Classified / root cause: manufacturing process

FDA source

MICROVENTION INC. began a recall of 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... on 2024-12-11. FDA classified it as Class II and gives the reason as "Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1121-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-11
Posted: 2025-02-07
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: QCA Intracranial Coil-Assist Stent
Reason for recall: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On December 11, 2024, MicroVention Europe SARL aka Terumo Neuro issued a "Urgent Medical Device Recall" Notification to affected consignees via mail. Terumo Neuro asked consignees to take the following actions: 1. Review Inventory; 2. Inform and Forward Recall Notice; 3. Return Product; 4. Please complete and return the "Customer Acknowledgment Form"; 4. Contact Quality Department ; 5. Replacement or Credit of Returned Devices
Quantity in commerce: 11 units
Distribution: US: None OUS: China
Product codes and lots: Lot number: 0000456768

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1121-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1121-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-07

Product code QCA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)