SWAN-GANZ PACEPORT 931F75Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103003925), received between May 24, 2023 and May 24, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2023Break; Break

  IT WAS REPORTED THAT A DURING A CABG PROCEDURE, 5 CENTIMETERS OF THE 931F75 SWAN-GANZ CATHETER WAS MISSING FROM THE END. PRIOR TO INSERTION, THE ANESTHESIOLOGIST, DR. CHRISTIAN STATED HE FLUSHED ALL THE PORTS, TESTED THE BALLOON, WHICH INFLATED NORMALLY AND WAS UNREMARKABLE. THE BALLOON DID INFLATE APPROPRIATELY AND HAD NO LEAKS. THE BALLOON WAS THEN DEFLATED PRIOR TO INSERTION. THERE WERE 2 ANESTHESIOLOGISTS MANAGING THIS CATHETER, DR. CHRISTIAN DID THE NECESSARY PRE-TESTING OF THE CATHETER, FLUSHING IT, TESTING THE BALLOON, INSERTING THE CATHETER, AND THEN HE HANDED THE PATENT OFF TO DR. HERREN WHO WAS MONITORING THE CATHETER WHILE IT WAS IN PLACE AND IDENTIFIED THE SPIKE IN THE PRESSURE. THE ANESTHESIOLOGIST IDENTIFIED THAT THE TRANSDUCER WAS LEAKING AND BEGAN ATTEMPTS TO ASPIRATE OR FLUSH THE CATHETER THINKING IT WAS POSSIBLY A BLOOD CLOT, BOTH OF WHICH WERE UNSUCCESSFUL. WHEN READINGS COULD NOT BE CORRECTED, ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFULLY, HOWEVER CATHETER WAS VERY EASILY BACKED UP. THE CATHETER WAS EXCHANGED FOR A DIFFERENT CATHETER. THE USED CATHETER WAS EASILY PULLED AND PLACED ON A SIDE TABLE AND A NEW SWAN GANZ CATHETER WAS FLUSHED, CHECKED, INSERTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998279 ↗

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-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
• 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