SWAN-GANZ VIP 831F75 (REF 831F75P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00690103003031), received between Feb 4, 2022 and Nov 21, 2025 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K160084, K231248); 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PLACEMENT OF THE SWAN-GANZ CATHETER, WHEN TRYING TO FLOAT IT, THE CATHETER WOULD GET CAUGHT AROUND THE PATIENT'S AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD). TO REPLACE THE CATHETER THE PATIENT REQUIRED AN EMERGENT TRIP TO THE CATH LAB. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619256 ↗
• MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER, THERE WAS A PINHOLE SIZED LEAK BELOW ONE OF THE PORTS. THE CATHETER WAS EXCHANGED FOR A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416458 ↗
• MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER, THERE WAS A PINHOLE SIZED LEAK BELOW ONE OF THE PORTS. THE CATHETER WAS EXCHANGED FOR A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416433 ↗
• MalfunctionSep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE, D5W LEAKED AT THE WHITE "PROXIMAL INJECTATE" AND BLUE TUBING CONNECTION OF A SWAN GANZ CATHETER. IT WAS NOTED THAT THE CATHETER WAS CONNECTED TO A CO-SET AND THAT THE CATHETER WAS USED IN THE PATIENT FOR 4 TO 6 WEEKS. NO ALLEGATION OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994781 ↗
• MalfunctionSep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE, D5W LEAKED AT THE WHITE "PROXIMAL INJECTATE" AND BLUE TUBING CONNECTION OF A SWAN GANZ CATHETER. IT WAS NOTED THAT THE CATHETER WAS CONNECTED TO A CO-SET AND THAT THE CATHETER WAS USED IN THE PATIENT FOR 4 TO 6 WEEKS. NO ALLEGATION OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994753 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER HAD MEDICATION LEAKAGE WHERE THE WHITE "PROXIMAL INJECTATE" AND BLUE TUBING CONNECT. LEAKAGE OCCURRED 6 DAYS AFTER INSERTION. NO ALLEGATION OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857256 ↗
• MalfunctionAug 13, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED ON MEDWATCH MW5172405 THAT, DURING DEVICE PREP, THE SWAN GANZ CATHETER COULD NOT BE DEFLATED. CATHETER WAS REMOVED FROM THE STERILE FIELD AND A NEW CATHETER WAS OPENED TO RESOLVE THE ISSUE. NO ALLEGATION OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801251 ↗
• MalfunctionMar 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED, THAT DURING USE, THE SWAN GANZ CATHETER PROVIDED INACCURATE CARDIAC OUTPUT. THE CUSTOMER STATES THAT THIS ISSUE HAS BEEN OCCURRING FOR THE PAST FEW MONTHS. PATIENT'S HAVE RECEIVED MEDICATION, ADDITIONAL TESTING AND DELAY IN EXTUBATION AS A RESULT OF THESE INACCURATE VALUES. NO PATIENT INJURIES WERE REPORTED. THE EXACT QUANTITY OF OCCURRENCES IS UNKNOWN. NO DEVICES ARE AVAILABLE FOR RETURN AS THEY WERE DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525915 ↗
• MalfunctionMar 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THIS SWAN GANZ CATHETER PROVIDED INACCURATE CARDIAC OUTPUT READINGS. THE PATIENT RECEIVED MEDICATION MANAGEMENT, ADDITIONAL TESTING (ECHOCARDIOGRAM), AND EXTUBATION WAS DELAYED AS A RESULT OF THE INACCURATE VALUES. NO PATIENT INJURY WAS REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520850 ↗
• MalfunctionFeb 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE SEVERAL INSTANCES OF INACCURATE BLOOD TEMPERATURE VALUES WITH SWAN GANZ THERMODILUTION CATHETERS OVER THE PAST FIVE YEARS. THE SWAN GANZ CATHETER DISPLAYED A TEMPERATURE THAT WAS DIFFERENT FROM THE PATIENTS ORAL TEMPERATURE. THERE IS NO FURTHER INFORMATION AVAILABLE. THERE IS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296481 ↗
• MalfunctionFeb 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A SWAN GANZ THERMODILUTION CATHETER. THE SWAN GANZ CATHETER DISPLAYED A TEMPERATURE THAT WAS DIFFERENT FROM THE PATIENTS ORAL TEMPERATURE. THE ORAL TEMPERATURE WAS 36.6C AND THE TEMPERATURE PROVIDED BY THE CATHETER WAS 35.8C. THERE WERE NO FAULT MESSAGES DISPLAYED. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295786 ↗
• MalfunctionDec 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, BEFORE USE IN PATIENT OF THIS SWAN GANZ CATHETER, THE BALLOON WAS RUPTURED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE CATHETER WAS RECEIVED FOR EVALUATION AND THE BALLOON DID NOT INFLATE DUE TO A TEAR AND THE EDGES OF LATEX DID NOT APPEAR TO MATCH AT THE TORN LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911375 ↗
• MalfunctionAug 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENTS CENTRAL VENOUS PRESSURE (CVP) INCREASED FROM 6 TO 22 MMHG. THE CVP LINE WAS FLUSHED AND CHECKED FOR BLOOD RETURN. NO BLOOD RETURN NOTED, MEDICATIONS CAME BACK INTO SYRINGE. THERE WAS NO ALLEGATION OF PATIENT INJURY. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081807 ↗
• MalfunctionMay 14, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING USE IN A PATIENT UNDERGOING CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) WITH THIS SWAN GANZ CATHETER, THE BALLOON DID NOT INFLATE DURING WEDGING. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON HAD TWO TEARS IN AND THE EDGES OF THE LATEX DID NOT APPEAR TO MATCH AT THE TORN LOCATION. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310568 ↗
• MalfunctionApr 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED A SWAN GANZ HAD INACCURATE TEMPERATURE VALUES. TEMPERATURE READ 35.7 WHILE ORAL TEMP READ 97.7. PATIENT HAVE BEEN INCORRECTLY TREATED WITH HYPOTHERMIA. IT WAS NOTED THAT THE TEMPERATURE CHANGE IS USED TO DETERMINE HEMODYNAMIC READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777191 ↗
• MalfunctionMar 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN 831F75 SWAN-GANZ CATHETER WAS COMPROMISED. BETWEEN THE 60-80CM MARK, THE TUBING APPEARED FLAT, AND THE WIRE WAS EXPOSED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492230 ↗
• MalfunctionJul 13, 2022Incorrect Measurement; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PATIENT USE IN THE CVICU, USING A SWAN GANZ CATHETER, THERE WERE ERRATIC PATIENT MEASUREMENTS OF THE CORE TEMPERATURE, WHILE CONNECTED TO THE HEMOSPHERE MONITOR. THE ISSUE WOULD TEMPORARILY RESOLVE IF THE CCO CABLE WAS UNPLUGGED FROM THE CATHETER AND THEN PLUGGED BACK IN. HOWEVER, THE TEMPERATURE WOULD BEGIN DRIFTING TO ABNORMALLY HIGH VALUES. REPORTED AS HIGH AS 115 DEGREES F, LEADING TO THE CESSATION OF CCO READINGS. THE CLINICIANS REPORTEDLY RAN A SUCCESSFUL CCO CABLE TEST ON THE CABLE INVOLVED. THE ISSUE STILL OCCURRED WHEN USING A REPLACEMENT CABLE AS WELL. THE CATHETER HAD REPORTEDLY BEEN INDWELLING FOR THREE DAYS PRIOR TO THIS ISSUE. A NEW CATHETER WAS NOT INSERTED. THE EXACT EVENT DATE IS UNKNOWN. THE CATHETER WAS NOT SAVED FOR RETURN. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT REPORTED. THE PATIENT DEMOGRAPHICS HAVE NOT BEEN PROVIDED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008825 ↗
• MalfunctionMay 11, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING USE WITH THIS SWAN-GANZ CATHETER, THAT THE CENTRAL VENOUS PRESSURE (CVP) AND THE PULMONARY ARTERY PRESSURE (PAP) READINGS WERE IN REVERSE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364205 ↗
• MalfunctionMay 11, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING USE WITH THIS SWAN-GANZ CATHETER, THAT THE CENTRAL VENOUS PRESSURE (CVP) AND THE PULMONARY ARTERY PRESSURE (PAP) READINGS WERE IN REVERSE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364122 ↗
• InjuryFeb 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE USING THIS SWAN GANZ CATHETER THE PHYSICIAN STATED THAT HE HAD A PATIENT WHO DEVELOPED A FEVER FROM THE CATHETER. THE INITIAL REPORTER STATED THAT SHE WOULD LIKE TO KNOW THE CHEMICAL COMPOSITION OF THE SWAN SO THAT THE PATIENT CAN BE TESTED FOR ALLERGY AND THEY CAN AVOID THE USE OF SWAN FOR THOSE PATIENTS. THIS PATIENT DEVELOPED A FEVER EVERY TIME HE HAD A SWAN CATHETER INSERTED. THE PATIENT WAS IN THE HOSPITAL FOR 3 MONTHS AND THE SWAN WAS TESTED ON HIM 4 TIMES IN THE PERIOD OF 3 MONTHS, WHERE HE DEVELOPED A FEVER EVERY TIME. ALL THE INFECTIOUS WORK-UP IS NEGATIVE. THERE WAS NO ALLEGATION MADE AGAINST THE FUNCTIONALITY OF THE SWAN AND ALL 4 CATHETERS WERE DISCARDED. PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13460174 ↗
• InjuryFeb 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE USING THIS SWAN GANZ CATHETER THE PHYSICIAN STATED THAT HE HAD A PATIENT WHO DEVELOPED A FEVER FROM THE CATHETER. THE INITIAL REPORTER STATED THAT SHE WOULD LIKE TO KNOW THE CHEMICAL COMPOSITION OF THE SWAN SO THAT THE PATIENT CAN BE TESTED FOR ALLERGY AND THEY CAN AVOID THE USE OF SWAN FOR THOSE PATIENTS. THIS PATIENT DEVELOPED A FEVER EVERY TIME HE HAD A SWAN CATHETER INSERTED. THE PATIENT WAS IN THE HOSPITAL FOR 3 MONTHS AND THE SWAN WAS TESTED ON HIM 4 TIMES IN THE PERIOD OF 3 MONTHS, WHERE HE DEVELOPED A FEVER EVERY TIME. ALL THE INFECTIOUS WORK-UP IS NEGATIVE. THERE WAS NO ALLEGATION MADE AGAINST THE FUNCTIONALITY OF THE SWAN AND ALL 4 CATHETERS WERE DISCARDED. PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13460170 ↗
• InjuryFeb 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE USING THIS SWAN GANZ CATHETER THE PHYSICIAN STATED THAT HE HAD A PATIENT WHO DEVELOPED A FEVER FROM THE CATHETER. THE INITIAL REPORTER STATED THAT SHE WOULD LIKE TO KNOW THE CHEMICAL COMPOSITION OF THE SWAN SO THAT THE PATIENT CAN BE TESTED FOR ALLERGY AND THEY CAN AVOID THE USE OF SWAN FOR THOSE PATIENTS. THIS PATIENT DEVELOPED A FEVER EVERY TIME HE HAD A SWAN CATHETER INSERTED. THE PATIENT WAS IN THE HOSPITAL FOR 3 MONTHS AND THE SWAN WAS TESTED ON HIM 4 TIMES IN THE PERIOD OF 3 MONTHS, WHERE HE DEVELOPED A FEVER EVERY TIME. ALL THE INFECTIOUS WORK-UP IS NEGATIVE. THERE WAS NO ALLEGATION MADE AGAINST THE FUNCTIONALITY OF THE SWAN AND ALL 4 CATHETERS WERE DISCARDED. PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13460164 ↗
• InjuryFeb 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE USING THIS SWAN GANZ CATHETER THE PHYSICIAN STATED THAT HE HAD A PATIENT WHO DEVELOPED A FEVER FROM THE CATHETER. THE INITIAL REPORTER STATED THAT SHE WOULD LIKE TO KNOW THE CHEMICAL COMPOSITION OF THE SWAN SO THAT THE PATIENT CAN BE TESTED FOR ALLERGY AND THEY CAN AVOID THE USE OF SWAN FOR THOSE PATIENTS. THIS PATIENT DEVELOPED A FEVER EVERY TIME HE HAD A SWAN CATHETER INSERTED. THE PATIENT WAS IN THE HOSPITAL FOR 3 MONTHS AND THE SWAN WAS TESTED ON HIM 4 TIMES IN THE PERIOD OF 3 MONTHS, WHERE HE DEVELOPED A FEVER EVERY TIME. ALL THE INFECTIOUS WORK-UP IS NEGATIVE. THERE WAS NO ALLEGATION MADE AGAINST THE FUNCTIONALITY OF THE SWAN AND ALL 4 CATHETERS WERE DISCARDED. PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13460105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160084, K231248. One submission often covers many models, so check the product and lot details in each record.

• Z-2203-2026 · Apr 8, 2026 · Open, Classified
  Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
• 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
• 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