SWAN-GANZ PACEPORT 780F75MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103197341), received between Oct 11, 2022 and Oct 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT, BEFORE USE, THE BALLOON ON THE SWAN-GANZ CATHETER WAS RUPTURED. THE DEVICE WAS BEING USED WITH A HEMOSPHERE MONITOR. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS RETURNED FOR EVALUATION AND THE CENTRAL AREA OF THE BALLOON LATEX WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577660 ↗

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 deter
• 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 determi
• 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 determ