Stent LEV2512-PMARecalls & reported problems
Microvention, Inc. · LVIS EVO · Class 3 · Implant
All models of Stent (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429117743), received between Jul 9, 2024 and Jul 9, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: THROMBUS FORMATION ON THE DEVICE, POST IMPLANT. THE THROMBUS WAS TREATED WITH A BOLUS AND A DOSE OF ANTI-CLOTTING MEDICATION WAS ADMINISTERED AS SOON AS THE THROMBUS FORMATION WAS NOTICED. PRODUCT IS STILL IMPLANTED INSIDE THE PATIENT. THE PATIENT DID FINE AND WENT HOME THE NEXT DAY.
Patient problems: Thrombosis/Thrombus
MAUDE report 19705989 ↗
Other Intracranial coil-assist stent devices
- Neuroform Atlas M003UZAS30240Stryker Corporation · Intracranial coil-assist stent13 reports
- Neuroform Atlas M003UZAS30210Stryker Corporation · Intracranial coil-assist stent12 reports
- Neuroform Atlas M003UZAS45210Stryker Corporation · Intracranial coil-assist stent11 reports
- Neuroform Atlas M003UZAS45300Stryker Corporation · Intracranial coil-assist stent10 reports
- Neuroform Atlas M003UZAS40210Stryker Corporation · Intracranial coil-assist stent9 reports
- Stent LEV3018-PMAMicrovention, Inc. · Intracranial coil-assist stent7 reports
- Neuroform Atlas M003UZAS40240Stryker Corporation · Intracranial coil-assist stent1 death6 reports
- Neuroform Atlas M003UZAS30150Stryker Corporation · Intracranial coil-assist stent6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page