LVIS Intraluminal Support Device Stent Recalled Dimensional Nonconformance
MICROVENTION INC. is recalling LVIS Intraluminal Support Devices due to dimensional nonconformance and incorrect device configuration that may result from manufacturing commingling, creating risk of vessel injury, thrombosis, or neurological events.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential for serious injury including vessel rupture, thrombosis, and ischemic neurological events, meeting the Severe criterion for Class II with risk-of-harm.
Plain-English summary
MICROVENTION INC. is recalling the LVIS Intraluminal Support Device (also called a stent-assisted coiling device) in three size variants: 4.0 mm x 22 mm x 18 mm (REF 214022-CAS), 4.5 mm x 18 mm x 14 mm (REF 214518-CAS), and 3.5 mm x 17 mm x 13 mm (REF 213517-CAS). The recall affects 38 units distributed to China.
The devices are being recalled because they may have dimensional nonconformance and/or incorrect device configuration due to commingling during manufacturing. An oversized device may lead to increased vessel wall stress, neointimal hyperplasia, or vessel injury or rupture. An undersized device may lead to incomplete expansion, malposition, acute stent thrombosis, distal embolization, or ischemic neurological events.
The affected lot numbers are 0000616462, 0000619851, 0000552987, and 0000551725. Customers who have these devices should stop use and contact MICROVENTION INC. for further guidance.
The recalled product
- 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
- Manufacturer
- MICROVENTION INC.
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lots: 0000616462
- 0000619851
- 0000552987
- 0000551725. UDI: (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)240610(17)270531(10)0000616462
- (01)00842429115961(11)240610(17)270531(10)0000619851
Distribution
Distribution scope not specified by the agency.
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