Regard™ CV01005HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717114895), received between Jun 17, 2022 and Jun 17, 2022 — classified as 1 malfunction.

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

2 FDA recall records 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. Oct 20, 2022Terminated

   Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

   Z-0303-2023 · Root cause: Component change control · FDA record ↗

2. Jun 3, 2022Terminated

   Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

   Z-1407-2022 · 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.

• MalfunctionJun 17, 2022Delivered as Unsterile Product; Packaging Problem

  A NON-STERILE BAG DECANTER WAS ADDED TO THIS KIT AS A SUB ITEM IN PLACE OF THE STERILE VERSION. THE KIT IS NOT STERILIZED PRIOR TO DISTRIBUTION, SO THE KIT CONTENTS ARE REQUIRED TO BE STERILE PRIOR TO ADDING TO THE KIT. THE BAG DECANTER IS REQUIRED TO BE STERILE FOR USE, BUT WAS ADDED TO THE KIT AND WAS DISTRIBUTED TO THE DIRECT ACCOUNT AS NON-STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733726 ↗