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U.S. Department of Health and Human Services

Class 2 Device Recall LVIS Intraluminal Support Device

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 Class 2 Device Recall LVIS Intraluminal Support Devicesee related information
Date Initiated by FirmDecember 11, 2024
Date PostedFebruary 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1121-2025
Recall Event ID 96114
PMA NumberP170013 
Product Classification Intracranial coil-assist stent - Product Code QCA
ProductMicoVention 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.
Code Information Lot number: 0000456768
Recalling Firm/
Manufacturer		 MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information ContactTerrence Callahan
714-247-8159
Manufacturer Reason
for Recall		Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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
Quantity in Commerce11 units
DistributionUS: None OUS: China
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = QCA
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