Regard™ CV00332ORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717104209), received between Dec 20, 2019 and Dec 20, 2019 — 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.

• MalfunctionDec 20, 2019Material Puncture/Hole

  HOLE IN THE VENTED BAG THAT DID NOT APPEAR TO GO THROUGH TO THE BACK TABLE COVER OF THE STERILE CUSTOM SURGICAL KIT. THE HOLE IN THE VENTED BAG WAS IDENTIFIED WHILE UNBOXING THE KIT OUT OF THE SHIPPING CONTAINER. THE PACK WAS DISCARDED PRIOR TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 9506480 ↗