FDA Medical Device Recalls (openFDA)
MICROVENTION INC.: 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
- Recall number
- Z-2200-2026
- Recalling firm
- MICROVENTION INC.
- 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
- Status
- Open, Classified
- Initiated
- 2026-04-06
- Posted
- 2026-05-14
- Terminated
- not on file
- Reason
- 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
- 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 mvchinaqa@microvention.com If you have questions about this recall contact firm at max.huang@microvention.com
- Quantity
- 38
- Distribution
- International distribution to the country of China.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- P170013
- Product code
- QCA
- Firm FEI
- 3013556777
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28