SWAN-GANZ 70CC2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103002799), received between Oct 22, 2024 and Feb 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K043103); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT OF THIS 70CC2 CABLE, THE VALUES PROVIDED WERE NOT ACCURATE ACCORDING TO PATIENT STATUS. THE VALUES PROVIDED BY THE CABLE WERE COMPARED WITH THE ONES PROVIDED BY A BLOOD GAS ANALYSIS AND THEY WERE ABOUT 20 POINTS OF DIFFERENCE. EXACT INCORRECT VALUES COULD NOT BE PROVIDED. NO ERROR MESSAGE WAS DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419047 ↗
• MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, THE 70CC2 CABLE MALFUNCTIONED DURING USE. THE HEMOSPHERE MONITOR SHOWED THE BLOOD TERMPEARTURE RAPIDLY CHANGING FROM 35 TO 45 C. THIS CAUSED NO HARM TO THE PATIENT BUT CAUSED A DELAY IN OBTAINING VALUES POST-CABG. THE CUSTOMER TRIED CHANGING OUT THE HEMOSPHERE BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER THEN TRIED CHANGING OUT ALL THE CABLES AND THE ISSUE WAS RESOLVED. THERE WAS NO PHYSICAL DAMAGE TO THE CABLES. THE DEVICE WILL BE AVAILBLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402774 ↗
• MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, THE 70CC2 CABLES HAVE BEEN MALFUNCTIONING DURING USE. THE CUSTOMER HAS BEEN EXPERIENCING TEMPERATURE READING FLUCTUATIONS IN MULTIPLE CASES. THE ERROR MESSAGE OF "FAULT: CO- CATHETER VERIFICATION, USE BOLUS MODE" ALERT IS PRESENT SOMETIMES, BUT NOT EVERY OCCURRENCE. THERE WAS NO RESOLUTION WHEN CHANGING MACHINES AND/OR CABLES. THERE WAS NO PHYSICAL DAMAGE TO THE CABLES IN ANY OF THE CASES. THERE WERE NO PATIENT INJURIES REPORTED. NO DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401759 ↗
• MalfunctionOct 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A TEMPERATURE FLUCTUATION BETWEEN MONITORS. THE CO-CCO WAS NOT WORKING. THE CLINICIAN SWAPPED TO KNOWN WORKING 70CC2 CABLE USING THE SAME MONITOR AND ACCESSORIES AND EVERYTHING WORKED CORRECTLY. NO PATIENT INJURY WAS REPORTED, EVENT OCCURRED BEFORE USE. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2024: THE CUSTOMER WAS USING A HEMOSPHERE. THE MONITOR WAS DISPLAYING TEMPS OF 50 AND 45 THEN WHEN THEY USED A DIFFERENT CABLE THE TEMPERATURE WAS 35.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043103. One submission often covers many models, so check the product and lot details in each record.

• Z-0942-2012 · Sep 12, 2008 · Terminated
  Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monit
• Z-0262-2008 · May 17, 2007 · Terminated
  Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.6