Regard™ CV00361PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10194717107255), received between Jun 24, 2021 and Jul 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2021Tear, Rip or Hole in Device Packaging

  HOLES DISCOVERED IN THE VENTED BAGS AND THROUGH TO THE BACK TABLE COVER. NO HARM TO PATIENT, NO DELAY TO CASE. PACK WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225886 ↗
• MalfunctionJul 13, 2021Material Split, Cut or Torn

  TEARS WERE DISCOVERED IN THE VENTED BAGS AND SOMETIMES THROUGH TO THE BACK TABLE COVER. NO HARM TO PATIENT AND NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159499 ↗
• MalfunctionJun 24, 2021Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  HOLES DISCOVERED IN VENTED BAGS OF ROI CPS, LLC CUSTOM PROCEDURE KIT 800208016 LOTS 86469P AND 78330P. EVENT DATE IS UNKNOWN. CUSTOMER BELIEVED IT WAS INTERNAL MISHANDLING OF THE PACKS THAT CAUSED THE DAMAGE. NO HARM TO PATIENT, NO CASE DELAY AND NEW PACKS WERE PULLED FROM INVENTORY. REPORTING DUE TO THE BREACH IN THE STERILE POUCH.

  Patient problems: Insufficient Information

  MAUDE report 12063720 ↗