MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.
This recall is currently active, issued February 7, 2025. It was issued by Microvention Inc..
- Company
- Microvention Inc.
- Recall Initiated
- December 11, 2024
- Posted
- February 7, 2025
- Recall Number
- Z-1121-2025
- Quantity
- 11 units
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Distribution
US: None OUS: China
Lot / Code Info
Lot number: 0000456768
Root Cause
Nonconforming Material/Component
Action Taken
On December 11, 2024, MicroVention Europe SARL aka Terumo Neuro issued a "Urgent Medical Device Recall" Notification to affected consignees via mail. Terumo Neuro asked consignees to take the following actions: 1. Review Inventory; 2. Inform and Forward Recall Notice; 3. Return Product; 4. Please complete and return the "Customer Acknowledgment Form"; 4. Contact Quality Department ; 5. Replacement or Credit of Returned Devices