SWAN-GANZ CCOMBO 746F8Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103002881), received between Jul 11, 2018 and Mar 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K160084); 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 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.

• MalfunctionMar 16, 2020Component Missing

  ELDERLY PATIENT WITH HISTORY OF SEVERE AORTIC STENOSIS UNDERGOING A CORONARY ARTERY BYPASS GRAFT X 2 WITH AORTIC VALVE REPLACEMENT. WHEN THE EDWARDS LIFESCIENCE SWAN-GANTZ WAS CHECKED PRIOR TO USAGE, THERE WAS NO BALLOON ON THE SWAN-GANTZ DEVICE. THE DEVICE WAS NOT USED ON THE PATIENT, NO HARM TO PATIENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 9834734 ↗
• MalfunctionJul 11, 2018Failure to Calibrate

  PHYSICIAN COULD NOT GET THE SWAN-GANZ TO CALIBRATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7676978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160084. One submission often covers many models, so check the product and lot details in each record.

• Z-0763-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians
• Z-0762-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly det
• Z-0764-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly de
• Z-0765-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly dete