Merit Medical® 00884450184233Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
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 00884450184233), received between May 13, 2026 and May 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Product Quality 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
- Product Quality Problem1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Product Quality Problem
CUSTOMER REPORTS A PPATIENT HAD RIGHT RADIAL AND RIGHT FEMORAL ARTERY ACCESSES FOR CHRONIC TOTAL OCCLUSION INTERVENTION. DURING PROCEDURE, RADIAL AND FEMORAL ARTERIAL TRANSDUCED BLOOD PRESSURE SIGNIFICANTLY DROPPED SIMULTANEOUSLY FROM 160S TO 60S. THERE WAS A DISCREPANCY BETWEEN NON-INVASIVE BLOOD PRESSURE AND TRANSDUCED PRESSURE. DUE TO LOW TRANSDUCED PRESSURE, PRESSORS AND INOTROPES WERE ADMINISTERED. PATIENT WAS INTUBATED. CHANGED OUT ACIST TRANSDUCER, SO BELIEVE PROBLEM WAS IN MALFUNCTIONING CONSUMABLE/DISPOSABLE MANIFOLD.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 25163776 ↗
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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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