LVIS Intraluminal Support Device recall
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…
Why was LVIS Intraluminal Support Device recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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,
- 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…
- Recalling firm
- MICROVENTION INC.
- Quantity
- 38
- Distribution
- International distribution to the country of China.
- Recall date
- May 20, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)