SWAN-GANZ PACEPORT 991F8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103151961), received between Sep 12, 2022 and Sep 12, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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.

• InjurySep 12, 2022Material Separation; Material Separation

  IT WAS REPORTED VIA MEDWATCH REPORT 0039 0111 2022 0018 THAT A PATIENT BECAME HYPOTENSIVE WITH VENTRICULAR ARRHYTHMIA UPON PLACEMENT OF A MODEL 991F8 SWAN GANZ PACING CATHETER. TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A LARGE PERICARDIAL EFFUSION WITH TAMPONADE. A PERICARDIAL WINDOW WAS PERFORMED AND INJURY TO THE RIGHT VENTRICLE WAS FOUND, WHICH REQUIRED PRIMARY REPAIR WITH PLACEMENT OF A PERICARDIAL DRAIN. WHEN THE CATHETER WAS REMOVED, THE BALLOON WAS FOUND SHEARED OFF. THE DEVICE WAS SAVED FOR RETURN.

  Patient problems: Cardiac Tamponade

  MAUDE report 15402163 ↗

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-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
• 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