SWAN-GANZ CCOMBO 744F75Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103002850), received between Nov 6, 2025 and Nov 6, 2025 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER, DURING A MITRAL VALVE REPLACEMENT (MVR), THE CATHETER WAS FOUND TO HAVE PERFORATED THE RIGHT VENTRICLE. AFTER INSERTION OF THE CATHETER INTO THE PATIENT, IT BENT AT A SHARP ANGLE IN THE RIGHT VENTRICLE AND REACHED THE PULMONARY ARTERY. DURING MVR, THE BENT PART OF THE CATHETER CAME INTO CONTACT WITH THE RIGHT VENTRICULAR WALL, RESULTING IN THE PERFORATION. THIS WAS DISCOVERED DURING CHEST CLOSURE AS BLEEDING WAS OBSERVED. AFTER CHECKING, THE CATHETER WAS FOUND PROTRUDING FROM THE APEX OF THE HEART, SO A PATCH WAS APPLIED TO REPAIR THE DAMAGE. THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER ISSUES. NO EXTENSION OF THE HOSPITALIZATION PERIOD FOR TREATMENT WAS REQUIRED. PATIENT HAS SINCE RECOVERED. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Intraoperative Cardiac Injury

  MAUDE report 23492335 ↗

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-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-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-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-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