Z-2200-2026Class II

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL)...

Name: Z-2200-2026 LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL)...
Creator: Microvention Inc.
Published: 2026-04-06
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2026-04-06 / Open, Classified / root cause: manufacturing process

FDA source

MICROVENTION INC. began a recall of LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x... on 2026-04-06. FDA classified it as Class II and gives the reason as "Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress...". 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-2200-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-06
Posted: 2026-05-14
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
Product code: QCA Intracranial Coil-Assist Stent
Reason for recall: Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: On 4/6/2026, recall notices with TERUMO NEURO listed on notice top, were emailed to customers who were asked to do the following: 1) Stop using and quarantine affected devices. 2) Complete and return the acknowledgement form via email to -Distributors should provide the recall notice to medical facilities or users to whom you have distributed affected products. - Distributors should reconcile the completed forms from all customers and submit to recalling firm via email [email protected] If you have questions about this recall contact firm at [email protected]
Quantity in commerce: 38
Distribution: International distribution to the country of China.
Product codes and lots: Lots: 0000616462, 0000619851, 0000552987, 0000551725. UDI: (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115930(11)240325(17)270228(10)0000551725, (01)00842429115930(11)240325(17)270228(10)0000551725, (01)00842429115930(11)240610(17)270531(10)0000616462, (01)00842429115930(11)240610(17)270531(10)0000616462, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2200-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2200-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-14

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)