Regard™ GS00085ACRecalls & reported problems
Roi Cps, LLC · MINOR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10194717113836), received between Oct 20, 2023 and Jan 3, 2024 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available5
Patient problems
- Insufficient Information5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HOLE WAS NOTED IN THE VENTED BAG HOLDING THE CONVENIENCE KIT.
Patient problems: Insufficient Information
MAUDE report 18439930 ↗MalfunctionDec 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THERE WAS A HOLE IN THE BACK TABLE COVER AND IN THE VENTED BAG. THERE WAS NO PATIENT CONTACT AND A NEW KIT WAS PULLED FROM STERILE SUPPLY PRIOR TO START OF CASE.
Patient problems: Insufficient Information
MAUDE report 18304578 ↗MalfunctionDec 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HOLE WAS DISCOVERED IN THE BACK TABLE COVER AND IN THE VENTED BAG HOLDING THE KIT. THERE WAS NO PATIENT CONTACT AND A NEW PACK WAS PULLED FROM STERILE SUPPLY.
Patient problems: Insufficient Information
MAUDE report 18302807 ↗MalfunctionDec 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HOLE WAS DISCOVERED IN THE VENTED BAG WITH NO HOLE IN THE BACK TABLE COVER. THERE WAS NO PATIENT CONTACT AND A NEW PACK FROM STERILE SUPPLY WAS OPENED FOR THE CASE.
Patient problems: Insufficient Information
MAUDE report 18301801 ↗MalfunctionOct 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HOLE WAS DISCOVERED IN THE VENTED BAG. THE HOLE WAS DISCOVERED DURING SET UP. THE KIT WAS DISCARDED AND A NEW ONE WAS PULLED FROM STERILER SUPPLY.
Patient problems: Insufficient Information
MAUDE report 17977785 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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