Regard™ CV00979ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717101949), received between May 23, 2022 and May 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 20, 2022Terminated

   A nonsterile component was packaged in a sterile convenience kit.

   Z-1295-2022 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 23, 2022Delivered as Unsterile Product; Use of Device Problem

  ROI CPS, LLC BECAME AWARE, AFTER RECEIVING AN INQUIRY FROM AN END USER FACILITY REGARDING A NON-STERILE ULTRASOUND GEL 20GM NS BEING USED IN A STERILE CV MINOR PROCEDURE KIT. THE NON-STERILE ITEM IS IN A FOIL PACKAGE THAT IS LABELED AS NON-STERILE AND CANNOT BE STERILIZED IN THE ROI CPS, LLC STERILIZATION CYCLE DUE TO PENETRATION OF EO GAS BEING PREVENTED BY THE FOIL PACKAGING. THE GEL IS REQUIRED TO BE STERILE FOR USE IN THE CV MINOR PROCEDURE KIT.

  Patient problems: Insufficient Information

  MAUDE report 14477747 ↗