Regard™ CV01060ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10194717119173), received between Sep 5, 2024 and Sep 18, 2024 — classified as 2 malfunctions.

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.

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 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Insufficient Information

  MAUDE report 20251117 ↗
• MalfunctionSep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Insufficient Information

  MAUDE report 20144712 ↗