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Merit Medical® 00884450330975Recalls & reported problems

Argon Critical Care Systems Singapore Pte. Ltd. · 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 00884450330975), received between Feb 3, 2021 and Feb 3, 2021 — 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use 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.

  • InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE ACCOUNT ALLEGES THAT DURING POST-OP MONITORING OF A HEART SURGERY PATIENT, THE CLINICAL STAFF BELIEVED THAT THE PATIENT DEVELOPED HYPERTENSION DUE TO PRESSURE CHANGES DEMONSTRATING R-R VARIABILITY. THE PATIENT WAS MEDICALLY TREATED FOR HYPERTENSION [CATAPRESAN IV] WITH NO ADDITIONAL CONSEQUENCES TO REPORT. THE ACCOUNT ALLEGES THAT THE INACCURATE PRESSURE CHANGES MAY BE RELATED TO A FAULTY TRANSDUCER INTERFACE CABLE. THE CABLE HAS BEEN TESTED AT ANOTHER SITE AND THE FAULT WAS REPRODUCIBLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11274003 ↗

Other System, measurement, blood-pressure, non-invasive devices

All System, measurement, blood-pressure, non-invasive devices →

Sources and updates

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