CO-SET+ 93522Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103003260), received between Sep 2, 2022 and Jun 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THIS CO-SET INJECTATE PROBE CABLE WAS UNABLE TO OBTAIN BASAL TEMPERATURE. THEN, 0 C DEGREE WAS USED TO ESTIMATE THE CARDIAC OUTPUT (CO) AND THE CALCULATION WAS TOO HIGH. VALUES WERE UNABLE TO BE USED. A NOTE SAYING: "THE INJECTABLE THERMISTOR IS NOT CONNECTED. 0C WILL BE USED AS THE INJECTABLE TEMPERATURE" WAS DISPLAYED. THE CO WAS ALSO CALCULATED WITH FICK FORMULA BUT IT WAS MORE INCORRECT WAY OF ESTIMATE CO SINCE THE PATIENT HAS BEEN THERE BEFORE AND IT WAS CALCULATED WITH THERMODILUTION. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201144 ↗
• MalfunctionSep 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE 93522 CO SET CABLE WOULD NOT READ A TEMPERATURE OF THE INJECTATE AT ALL AND IT WOULD READ THE TEMPERATURE LOW. IF THE TEMPERATURE WAS READ LOW IT WOULD GIVE FALSELY HIGH VALUES FOR CARDIAC INDEX OUTPUT AND SKEW THE REST OF THE HEMODYNAMIC PROFILE. WHEN COMPARING THESE THERMODILUTION VALUES TO THE FICK CARDIAC INDEX AND OUTPUT CALCULATED FROM AN SVO2 FROM THE SAME PATIENT IT WAS CLEAR THAT SOMETHING WAS AMISS. THEY KNEW WHEN THEY WERE RECEIVING OUTPUTS OF 14 TO 15 THERE WAS NO WAY IT WAS ACCURATE. PATIENTS WERE NOT TREATED BASED ON THESE NUMBERS. THEY WERE ABLE TO TROUBLESHOOT BY EXCHANGING THE SUSPECT CABLE. PATIENT DEMOGRAPHICS WERE UNAVAILABLE. THIS WAS DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352449 ↗
• MalfunctionSep 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE 93522 CO SET CABLE WOULD NOT READ A TEMPERATURE OF THE INJECTATE AT ALL AND IT WOULD READ THE TEMPERATURE LOW. IF THE TEMPERATURE WAS READ LOW IT WOULD GIVE FALSELY HIGH VALUES FOR CARDIAC INDEX OUTPUT AND SKEW THE REST OF THE HEMODYNAMIC PROFILE. WHEN COMPARING THESE THERMODILUTION VALUES TO THE FICK CARDIAC INDEX AND OUTPUT CALCULATED FROM AN SVO2 FROM THE SAME PATIENT IT WAS CLEAR THAT SOMETHING WAS AMISS. THEY KNEW WHEN THEY WERE RECEIVING OUTPUTS OF 14 TO 15 THERE WAS NO WAY IT WAS ACCURATE. PATIENTS WERE NOT TREATED BASED ON THESE NUMBERS. THEY WERE ABLE TO TROUBLESHOOT BY EXCHANGING THE SUSPECT CABLE. PATIENT DEMOGRAPHICS WERE UNAVAILABLE. THIS WAS DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352416 ↗