Cleerly Labs v2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860001924114), received between Aug 8, 2024 and Aug 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Inaccurate Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Inaccurate Information; Inaccurate Information

  A 59 YEAR OLD UNDERWENT CCTA AND CLEERLY ANALYSIS DEMONSTRATING 3-VESSEL CORONARY ARTERY DISEASE (CAD) INCLUDING STAGE 2 (MODERATE) PLAQUE BURDEN (253 MM3 AND 13.7% PERCENT ATHEROMA VOLUME) AS WELL AS THREE CORONARY ARTERY DISEASE - REPORTING AND DATA SYSTEM (CAD-RADS) GRADE 3 (MODERATE) STENOSES INCLUDING THE RIGHT CORONARY ARTERY (RCA), THE, PROXIMAL LAD (PLAD) AND THE PROXIMAL CIRCUMFLEX (PCX). THERE WERE ALSO 7 MILD STENOSES (1-49%) NOTED IN THE RCA, LEFT MAIN, CX AND OM1. THE PATIENT'S CARDIOLOGIST RECOMMENDED THAT SHE UNDERGO CORONARY ARTERY BYPASS (CABG) SURGERY FOR HER 3-VESSEL CAD BUT SHE REFUSED AND ELECTED TO TRY MEDICAL MANAGEMENT.  FIVE MONTHS FOLLOWING THE CCTA AND CLEERLY ANALYSIS, THE PATIENT DEVELOPED ACUTE CHEST PAIN AND SHORTNESS OF BREATH AND WAS DIAGNOSED WITH AN ACUTE INFERIOR ST-ELEVATION MI (STEMI) IN THE RCA AND WAS SENT EMERGENTLY TO THE CARDIAC CATHETERIZATION LAB. IN THE CATH LAB, MULTIVESSEL CAD WITH HEMODYNAMIC SIGNIFICANCE WAS DEMONSTRATED. IN ADDITION SEVERE (CAD-RADS 4) STENOSES WERE NOTED IN THE PLAD (80%), OBTUSE MARGINAL (95%), MRCA (80%), DRCA (90%) AND RIGHT POSTERIOR DESCENDING CORONARY ARTERY (70%).

  Patient problems: Myocardial Infarction

  MAUDE report 19946009 ↗
• InjuryAug 8, 2024Inaccurate Information; Inaccurate Information

  A 67 YEAR OLD ASYMPTOMATIC PATIENT UNDERWENT A CCTA WITH CLEERLY ANALYSIS.  THE CLEERLY ANALYSIS DEMONSTRATED 2-VESSEL CORONARY ARTERY DISEASE (CAD) INCLUDING STAGE 2 (MODERATE) PLAQUE BURDEN (8.7% PERCENT ATHEROMA VOLUME) AS WELL AS TWO CORONARY ARTERY DISEASE - REPORTING AND DATA SYSTEM (CAD-RADS) GRADE 3 (MODERATE 50-69%) STENOSES INCLUDING THE MID RIGHT CORONARY ARTERY (MRCA) AND THE PROXIMAL LAD (PLAD).  THE MID-RCA STENOSIS WAS IDENTIFIED AS A HIGH RISK PLAQUE AS IT CONTAINED LOW-DENSITY PLAQUE (0.8 MM3) AND HAD POSITIVE REMODELING (REMODELING RATIO 1.2).   THE REPORT OF THE CCTA EXAM STATED "THERE IS MULTIVESSEL CORONARY ARTERY DISEASE THAT IS INDETERMINATE FOR HIGH GRADE OBSTRUCTION IN THE PROXIMAL TO MID SEGMENT OF THE LAD, MPI (MYOCARDIAL PERFUSION IMAGING) AND/OR INVASIVE CORONARY ANGIOGRAPHY MAY BE CONSIDERED".   THE PATIENT WAS REFERRED TO CARDIOLOGY BUT DID NOT PROCEED FOR FURTHER TESTING AS RECOMMENDED IN THE CCTA REPORT. PATIENT ALSO REFUSED PRESCRIPTION CAD MEDICATIONS, AND INSTEAD ELECTED TO PROCEED WITH NUTRACEUTICAL THERAPY.   APPROXIMATELY 3 MONTHS AFTER THE CCTA/ CLEERLY TEST, THE PATIENT DEVELOPED ACUTE CHEST PAIN AND UNDERWENT EMERGENT INVASIVE ANGIOGRAPHY A

  Patient problems: Ischemic Heart Disease

  MAUDE report 19946008 ↗