Regard™ CV01061Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10194717116981), received between Aug 23, 2023 and Sep 6, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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

Recent adverse event reports

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

• MalfunctionSep 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A TEAR WAS NOTED IN THE VENTED BAG PRIOR TO CASE SET UP.

  Patient problems: Insufficient Information

  MAUDE report 20159219 ↗
• MalfunctionAug 23, 2023Use of Device Problem; Use of Device Problem

  THERE WAS A SLIT IN THE VENTED BAG OF THE CONVENIENCE KIT THAT APPEARED TO BE FROM A BOX CUTTER LEAVING THE PACK NON-STERILE. THE SLIT WAS IDENTIFIED BY HOSPITAL STAFF PRIOR TO THE PACK BEING STORED IN STERILE SUPPLY AND WAS DISCARDED. THE KIT WAS NOT RETURNED FOR INVESTIGATION INTO THE INCIDENT. THE SOURCE OF THE CUT IS UNKNOWN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604458 ↗