Merit Medical® 00884450011874Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450011874), received between Jan 22, 2020 and Jan 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE ACCOUNT ALLEGES THAT DURING PREPARATIONS FOR A PERCUTANEOUS CORONARY INTERVENTION [PCI] PROCEDURE, A FOREIGN BODY WAS IDENTIFIED WITHIN THE CORONARY CONTROL SYRINGE [CCS]. THE CCS WAS FILLED SALINE AND INVERTED TO REMOVE ALL THE AIR FROM WITHIN THE SYRINGE WHEN A WHITE FOREIGN BODY WAS IDENTIFIED WITHIN THE BARREL. A NEW CCS WAS OPENED AND PREPPED FOR THIS PROCEDURE. NO PATIENT INTERACTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9618616 ↗
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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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