Stent LEV4021-PMARecalls & reported problems
Microvention, Inc. · LVIS EVO · Class 3 · Implant
All models of Stent (63)
Data updated Oct 18, 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 00842429117880), received between Aug 21, 2024 and Aug 21, 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 18, 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.
InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 M003UZAS30150Stryker Corporation · Intracranial coil-assist stent6 reports
- Neuroform Atlas M003UZAS40240Stryker Corporation · Intracranial coil-assist stent1 death6 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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