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Regard™ HT0951Recalls & reported problems

Resource Optimization & Innovation, L.L.C. · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10326053113984), received between Jun 18, 2019 and Jun 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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

  • Contamination /Decontamination Problem2

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 18, 2019Contamination /Decontamination Problem

    DID NOT REACH PT. SMALL BLACK PARTICLE FOUND IN STERILE BOWL (BOWL 32OZ GRADUATED) PRIOR TO USE. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8717368 ↗
  • MalfunctionJun 18, 2019Contamination /Decontamination Problem

    DID NOT REACH PT. SMALL PARTICLE FOUND IN STERILE BOWL PRIOR TO CASE START. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8717350 ↗

Other Cardiac Catheterization Kit devices

All Cardiac Catheterization Kit devices →

Sources and updates

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