Regard™ CV00357ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717106005), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2020Material Puncture/Hole

  HOLES, THAT APPEARD TO BE TEARING, WERE DISCOVERED IN THE VENTED BAGS OF THREE VASCULAR PACKS. NO PATIENT CONTACT AND WAS DISCOVERED PRIOR TO SETTING UP THE CASE. THIS WAS FOUND ON ROI CPS, LLC VASCULAR PACK # 800204005 LOTS: 78113E, 78305E AND 75118E.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10657991 ↗