SWAN-GANZ VIP 782F75MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103197303), received between Oct 4, 2023 and Mar 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 8, 2026Class IIOpen, Classified

   Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

   Z-2202-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026

  CALIBRATING THE SWAN MACHINE IN PREP FOR THE CASE IN CT KEPT ERRORING. CHANGED OUT OXIMETRY CABLE, AND REBOOTED SWAN MACHINE WITH NO CHANGE. SWITCHED OUT THE KIT AND THE ERROR CODE ENDED RULING THE KIT BEING FAULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480977 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BALLOON OF A SWAN GANZ CATHETER CAME OFF DURING A PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ectopic Heartbeat; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999630 ↗
• MalfunctionOct 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF A SWAN GANZ CATHETER WAS MISSING DURING A PRE OP OPEN HEART SURGERY. AFTER CATHETER WAS FLOATED AND PLACED INTO THE PA, VENTRICULAR ECTOPY WAS NOTICED. IT WAS SUSPECTED THAT THE CATHETER FLIPPED BACK INTO THE RIGHT VENTRICLE. PHYSICIAN PULLED BACK INTO THE SVC, RA TO REFLOAT THE CATHETER, BUT BALLOON DID NOT INFLATE. PHYSICIAN REMOVED THE CATHETER FROM THE SHEATH TO EXAMINE AND NOTICED A SMALL DONUT SHAPED RUBBERIZED MATERIAL AT THE PROXIMAL AND DISTAL AREA OF THE BALLOON AND THAT THE MIDDLE SECTION OF THE BALLOON WAS MISSING. A NEW SWAN GANZ WAS EXCHANGED AND USED WITHOUT ISSUES. THE SURGERY WENT WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999616 ↗
• MalfunctionOct 4, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH THIS SWAN-GANZ CATHETER (782F75M, LOT NUMBER UNKNOWN). PER THE SALES REPRESENTATIVE, DURING A CABG PROCEDURE, AFTER THE PATIENT CAME OFF THE PUMP, THE SWAN DID NOT SHOW A PA WAVEFORM. THE ANESTHESIOLOGIST REPOSITIONED THE SWAN BACK UNTIL A WAVEFORM APPEARED. WHEN THE SURGERY WAS COMPLETED, THE ANESTHESIOLOGIST NOTICED THAT THERE WAS BLOOD ON THE FLOOR, BUT NEVER FOUND THE REASON. THE PATIENT WAS TRANSFERRED TO THE ICU AND CONNECTED TO THE HEMOSPHERE. THE TEMPERATURE WAS NEVER ACCURATE READING 91 DEGREES. THE SWAN WOULD NOT WEDGE, EVEN WITH ADVANCEMENT. WHEN THE SWAN WAS DISCONTINUED, THE NURSE NOTED THAT THERE WAS BLOOD IN THE THERMISTOR ON THE 70CC2 CABLE. THERE WAS NO BLOOD ON THE OUTSIDE OF THE CABLE. THERE WAS A CLOT IN THE THERMISTOR AS WELL. THERE WAS NO TROUBLESHOOTING DONE. THE NON-EDWARDS PRODUCTS INVOLVED WERE THE INTRODUCER AND ARROW KIT. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17873823 ↗

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-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-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-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