HemoSphere Alta ALTACR1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103217971), received between May 30, 2025 and Feb 27, 2026 — 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.

• MalfunctionFeb 27, 2026Incorrect Measurement

  AS REPORTED, DURING USE THIS HEMOSPHERE ALTA MONITOR WITH A SWAN GANZ CATHETER, UNSTABLE CENTRAL VENOUS PRESSURE (CVP) WAS PROVIDED (SEE IMAGES ATTACHED). IN ADDITION, VENTRICULAR STROKE VOLUME INDEX (VTDI) WAS NOT PROVIDED. AS PER CUSTOMERS OPINION THE ISSUE WAS CAUSED BY THE CATHETER NOT BEING POSITIONED CORRECTLY. THE PATIENT WAS NOT IN ATRIAL FIBRILLATION AND DID NOT HAVE ANY ARRHYTHMIAS. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466644 ↗
• MalfunctionDec 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ALTA CARDIAC MONITOR THE BLOOD TEMPERATURE WAS INCORRECT. THERE WAS NO ALERT OR ERROR MESSAGE FROM THE MONITOR. THE MONITOR WAS DISPLAYING TEMPERATURES OF 89 TO 91 DEGREES. AT THAT POINT IT WAS NOT CALCULATING CO VALUES EITHER. THE REP FIRST REPLACED THE CCO CABLE IN AN ATTEMPT TO TROUBLESHOOT, HOWEVER THE MONITOR AGAIN READ LOW TEMPERATURE WITH NO ALERT BUT WAS CALCULATING CO NUMBERS. TEMPERATURES WERE CONFIRMED BY FOLEY CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835470 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, THE HEMOSPHERE ALTA CARDIAC HAD OXIMETRY VALUE OUT OF RANGE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED EVENT. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118208 ↗