SWAN-GANZ HEMA70CC2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103217704), received between Jul 11, 2024 and Dec 12, 2025 — classified as 2 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. 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.

• MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, A CCO CABLE HAD LOW BLOOD TEMPERATURE READING AND COULD NOT CALCULATE CO. THE CCO CABLE HAD BLOOD TEMPERATURE OF 89 WHILE THE FOLEY CATHETER HAD 97. CABLE WAS CONNECTED TO AN ALTA MONITOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796392 ↗
• MalfunctionJul 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH THE ALTA MONITOR. THE MONITOR REPORTED 100/100 ON THE ARTERIAL LINE AFTER THE ACUMEN CUFF PRESSURE RELEASE, THIS WAS DURING PATIENT MONITORING. THIS OCCURRED DURING A TARGET MARKETING RELEASE AT A FACILITY. ALL PARAMETERS WERE REPORTING ACCURATELY AT THAT POINT. THE PHYSICIAN ATTEMPTED TO STOP AND RESTART CLEARSIGHT MONITORING. BUT AFTER STOPPING, THE CLINICIAN COULD NOT RESTART DUE TO THE ZEROING REQUIREMENT. THEY ATTEMPTED TO RE-ZERO, BUT COULD NOT DUE TO HEART REFERENCE SENSOR ZEROING STEP. THEY WERE SEEING THE CLEARSIGHT CUFF ZEROING. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721530 ↗