Regard™ HT00051QRecalls & reported problems
Roi Cps, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717110002), received between Jul 28, 2021 and Jul 28, 2021 — 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 18, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2021Material Puncture/Hole
HOLE IN VENTED BAG. DISCOVERED DURING SET UP. NO DELAY TO CASE. NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240725 ↗
Other Cardiac Catheterization Kit devices
- Medline Industries, Inc. DYNJ44700JMedline Industries, Inc. · Cardiac catheterization kit3 recalls1 report
- Medline Industries, Inc. ECVC2555Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ83089Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ0578916XMedline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. MNS9935Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC5540ACenturion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC2745Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC6505Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page