Ventrax™ Initial ReleaseRecalls & reported problems
Merit Medical Systems, Inc. · Class 2
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 00884450838167), received between Mar 11, 2026 and Mar 11, 2026 — 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
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THE SHEATH OF THE DEVICE WAS USED FOR APPROXIMATELY FIVE HOURS FOR A PVC ABLATION, NO ANTI-COAGULATION WAS USED. THE PATIENT WAS ADMITTED AND DUE TO PATIENT BEING DEAF A STROKE WAS NOT DETECTED FOR 24 HOURS. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Stroke/CVA
MAUDE report 24571535 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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