LVIS 213025-LVISRecalls & reported problems
Microvention, Inc. · Low-Profile Visualized Intraluminal Support · Class f · Implant
All models of LVIS (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425029961), received between Aug 29, 2025 and Aug 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (1 report).
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
- Activation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Activation Problem; Activation Problem
IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY THAT AN LVIS STENT DID NOT OPEN IN THE PROXIMAL END. AN LVIS INTRALUMINAL SUPPORT DEVICE (4.5 MMX23 MU) WAS DEPLOYED AS SUCH THAT THE DISTAL ASPECT OF THE DEVICE WAS WITHIN THE SUPRA-CLINOID PORTION OF THE INTERNAL CAROTID ARTERY AND THE PROXIMAL ASPECT OF THE STENT WAS WITHIN THE HORIZONTAL CAVERNOUS PORTION. THE DEPLOYMENT WIRE AND HEADWAY 21 MICROCATHETER WERE THEN WITHDRAWN. FINAL ANGIOGRAPHIC RUNS DEMONSTRATE SATISFACTORY PACKING OF THE ANEURYSM AND POSITION OF THE INTRALUMINAL SUPPORT DEVICE. THERE IS NO EVIDENCE OF PARENT ARTERY COMPLICATION OR THROMBOEMBOLIC COMPLICATION. THE HEADWAY 17 AND NEURON CATHETERS WERE WITHDRAWN. ANGIOGRAPHIC RUNS OF THE COMMON FEMORAL ARTERY DEMONSTRATE AN APPROPRIATE LEVEL OF VESSEL ACCESS WITHOUT EVIDENCE OF VESSEL WALL INJURY OR DISSECTION. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. IT WAS REPORTED THAT NO PART OF THE DEVICE WILL BE RETURNED AS IT REMAINS IMPLANTED. THE PATIENT WAS RETURNED TO THE PERIOPERATIVE CARE UNIT FOR FURTHER OBSERVATION. SUBJECT EXITED STUDY ON (B)(6) 2019.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22926856 ↗
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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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