MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297
FDA device recall Z-1121-2025 · posted 2025-02-07 · Open, Classified
Recall details
- Recalling firm
- MICROVENTION INC.
- Reason for recall
- Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- QCA
- Quantity affected
- 11 units
- Distribution
- US: None OUS: China
- Date initiated
- 2024-12-11
- Date posted
- 2025-02-07
- Location
- Aliso Viejo, CA
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