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Merit Medical® 00884450505410Recalls & 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 00884450505410), received between Jan 25, 2022 and Jan 25, 2022 — classified as 1 malfunction.

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

  • Fracture1
  • Material Separation1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionJan 25, 2022Fracture; Material Separation; Fracture; Material Separation

    THE ACCOUNT ALLEGES THAT THE WIRE BECOME UNRAVELED WHILE ATTEMPTING TO RETRACT THE NEEDLE ONCE THE WIRE PASSED THROUGH. THE PHYSICIAN ABANDONED THE PROCEDURE WHEN HE RETRACTED THE WIRE AND FOUND THAT A PIECE OF THE WIRE HAD BROKEN OFF AND LEFT BEHIND. RADIOLOGY VERIFIED THAT THERE WAS SOME ARTIFACT WITHIN THE IMAGE THAT APPEARED TO BE A PIECE OF THE BROKEN WIRE. THE PHYSICIAN CONFIRMED THE PATIENT WAS SAFE AND THERE WAS NO INJURY TO REPORT.

    Patient problems: Foreign Body In Patient

    MAUDE report 13344183 ↗

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Sources and updates

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