United StatesThe LVIS Intraluminal Support Device, REF/OD x TL x 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 (lots 0000616462, 0000619851, 0000552987, 0000551725) distributed to China is affected. It was recalled because commingling during manufacturing may cause dimensional nonconformance and/or incorrect device configuration, which could lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture, incomplete expansion/malposition, acute stent thrombosis, distal embolization, or ischemic neurological events.
What's being recalled
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
Recalling firm: Microvention Inc., Aliso Viejo, CA, United States.
How to identify it
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,
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution to the country of China.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)