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Merit Medical® 00884450620120Recalls & 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 00884450620120), received between Sep 23, 2022 and Sep 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1
  • Fluid/Blood Leak1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2022Crack; Fluid/Blood Leak

    MERIT MEDICAL CUSTOM MANIFOLDS HAVE BEEN NOTED TO HAVE AN ISSUE WITH THE BONDING CAUSING THE FLUID TO LEAK AND THE MANIFOLDS TO CRACK.

    Patient problems: Insufficient Information

    MAUDE report 15469995 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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