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ProGuide™ 00884450027875Recalls & reported problems

Merit Medical Systems, Inc. · Class 2 · Implant

All models of ProGuide (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450027875), received between Feb 7, 2023 and Feb 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 16, 2026.

Most reported problems

Device problems

  • Fracture3
  • Material Separation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 7, 2023Fracture; Material Separation; Fracture; Material Separation

    THE ACCOUNT ALLEGES THAT THE HUB ON THE DIALYSIS CATHETER CRACKED. NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16314119 ↗
  • MalfunctionFeb 7, 2023Fracture; Material Separation; Fracture; Material Separation

    THE ACCOUNT ALLEGES THAT THE HUB ON THE DIALYSIS CATHETER CRACKED. NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16314086 ↗
  • MalfunctionFeb 7, 2023Fracture; Material Separation; Fracture; Material Separation

    THE ACCOUNT ALLEGES THAT THE HUB ON THE DIALYSIS CATHETER CRACKED. NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16314080 ↗

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Sources and updates

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