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Regard™ CV00852GRecalls & reported problems

Roi Cps, LLC · CHEST · Class 2

Data updated Oct 16, 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 10194717112891), received between Nov 7, 2021 and Nov 7, 2021 — 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 16, 2026.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 7, 2021Device Contamination with Chemical or Other Material

    A FOREIGN OBJECT WAS FLOATING IN PITCHER ONCE SALINE WAS POURED. DISCOVERED DURING PROCEDURE. NO DELAY TO CASE. PITCHER WITH FOREIGN OBJECT WAS REMOVED FROM THE STERILE FIELD AND DISCARDED. NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12763266 ↗

Other Cardiovascular Procedure Kit devices

All Cardiovascular Procedure Kit devices →

Sources and updates

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