SWAN-GANZ CCOMBO V 774F75Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00690103146998), received between Mar 29, 2023 and Sep 28, 2026 — classified as 2 deaths, 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Feb 14, 2023Class IIOpen, Classified

   There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.

   Z-1380-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Fragmentation

  As reported, prior to patient use, the balloon of this Swan-Ganz catheter failed to inflate. There was no allegation of patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920933 ↗
• MalfunctionSep 28, 2026Deflation Problem

  It was reported that, during use, a Swan Ganz catheter had deflation difficulties. Balloon was tested prior to insertion without issue. Balloon was successfully floated however there was no passive deflation when instructed to deflate. Syringe was exchanged for a different syringe, but there was still no deflation and resistance was felt. Swan was kept in the patient who was then transferred to Intensive Care Unit. There was no patient injuries. Further information is unavailable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920846 ↗
• MalfunctionSep 15, 2026Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774218 ↗
• MalfunctionSep 15, 2026Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774203 ↗
• MalfunctionDec 9, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, THE BALLOON OF THIS SWAN-GANZ CATHETER RUPTURED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND RUPTURED AT THE CENTRAL AREA. RUPTURED EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED LOCATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760618 ↗
• DeathDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, IN A 69 YEARS OLD WOMAN WITH A LVAD (LEFT VENTRICULAR ASSIST DEVICE) SINCE 2014 TRANSFERRED FROM EXTERNAL REA (RESUSCITATION) WITH SUSPECTED INFECTION IN THE CONTEXT OF BRONCHOSPASM WITH VERY HIGH VENTILATION PRESSURES WITHOUT TENSION PNEUMOTHORAX AND WITH RV (RIGHT VENTRICLE) FAILURE AND SUBSEQUENT SUCTIONING OF THE LVAD VS LVAD INFLOW THROMBOSIS, THIS SWAN GANZ CATHETER, INSERTED IN THE INTERNAL JUGULAR VEIN ABOUT 16H BEFORE, WAS REPOSITIONED BECAUSE IT HAD STOPPED PROVIDING VALUES AND THEN A FULMINANT ARTERIAL-PULMONARY BLEEDING OCCURRED. PATIENT WAS PUT ON VA-ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION) AND MASSIVE TRANSFUSION WAS DONE. THE PATIENT DIED AROUND SIX HOURS LATER. USER COMMUNICATED THAT IT WAS NOT POSSIBLE TO DETERMINE IF THE EVENT WAS RELATED OR NOT TO THE DEVICE, BUT IT WAS NOTIFIED DUE TO TWO DEATHS (COMPLAINTS (B)(4) AND (B)(4)) WITHIN 3 CALENDAR DAYS IN THE INTENSIVE CARE UNIT WITH THE SAME TYPE OF SWAN-GANZ CATHETER. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23758998 ↗
• DeathDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING THE POSTOPERATIVE COURSE FOLLOWING 3-VESSEL CORONARY ARTERY BYPASS SURGERY, A SWAN-GANZ CATHETER WAS PLACED AT APPROXIMATELY 1:30 AM AFTER A PATIENT THERAPY-REFRACTORY SHOCK OF UNCLEAR ORIGIN. TEN MINUTES AFTER MEASURING THE PULMONARY WEDGE PRESSURE, THE PATIENT DEVELOPED AN ENDOBRONCHIAL HEMORRHAGE, CONFIRMED BY BRONCHOSCOPY AS BLEEDING FROM THE RIGHT LOWER LOBE OR SEGMENT 6 OF THE RIGHT LUNG. THIS LED TO AN INCREASING HEMODYNAMIC INSTABILITY AND BLOOD LOSS VIA BOTH INDWELLING PLEURAL DRAINS. AT AROUND 1:50 AM, THE DECISION WAS MADE TO INITIATE VA-ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION), BUT DESPITE ONGOING THERAPY WITH PRESSURE INFUSION, HIGH-DOSE VASOPRESSORS AND INOTROPES, CARDIAC ARREST OCCURRED AT 1.55 AM, AND RESUSCITATION WAS INITIATED. VA-ECMO WAS FINALLY IMPLANTED AT APPROX. 2:30 AM. DUE TO CONTINUED MASSIVE TRANSFUSION REQUIREMENTS, A BEDSIDE THORACOTOMY WAS PERFORMED, REVEALING A SEVERE BLEEDING FROM MULTIPLE SITES AT THE LUNG HILUM, WHICH COULD NOT BE SURGICALLY CONTROLLED. THE PATIENT DIED AT 03:56 AM. USER COMMUNICATED THAT IT WAS NOT POSSIBLE TO DETERMINE IF THE EVENT WAS RELATED OR NOT TO THE DEVICE. THE DEVICE WAS NOT RETAINED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23725942 ↗
• MalfunctionNov 6, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, DURING TESTING BEFORE USE IN PATIENT OF THIS SWAN-GANZ CATHETER, BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND RUPTURED AT THE CENTRAL AREA. THE BALLOON EDGES DID NOT MATCH AT THE RUPTURED REGION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485057 ↗
• MalfunctionOct 31, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER THE BALLOON RUPTURED. THE BALLOON WAS TESTED BEFORE INSERTION AND WAS WORKING PROPERLY. THE SWAN WAS FLOATED WITHOUT ANY ISSUES, THE CLINICIAN USED A 9F ARROW INTRODUCER. WHEN THE CLINICIAN TRIED TO DEFLATE THE BALLOON THERE WAS RESISTANCE AND THE BLOOD WAS VISIBLE IN INFLATION SYRINGE. THE SWAN WAS REMOVED AND THEY DID NOT PLACE A SECOND SWAN. THE BALLOON WAS NOT INTACT AND ONLY A SMALL PART OF THE BALLOON WAS VISIBLE. ON ECHO, THE ANESTHESIA TEAM REPORTED SEEING A SMALL HYPERECHOIC AREA NEAR THE PULMONIC VALVE. THE CABG PROCEDURE CONTINUED WITHOUT ANY ISSUES. THE SURGEON FLUSHED THE PULMONARY VEINS, THERE WERE NO ISSUES. AFTER THE CABG PROCEDURE WAS COMPLETED, ANOTHER ECHO WAS PERFORMED AND THE ANESTHESIA TEAM DID NOT SEE THE HYPERECHOIC AREA NEAR THE PULMONIC VALVE, AND INSTEAD SAW A HYPERECHOIC AREA IN THE RIGHT VENTRICLE. THEY COULD NOT CONCLUDE IF THIS AREA WAS A SMALL FRAGMENT OF THE BALLOON. THE PATIENTS POSTOP RECOVERY AND HEMODYNAMICS ARE NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437554 ↗
• MalfunctionOct 25, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, RIGHT AFTER OPENED THE PACKAGE OF THIS SWAN GANZ CATHETER, IT WAS FOUND THE BALLOON WAS BROKEN. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER PRODUCT EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA AND THE RUPTURED EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED LOCATION. PATIENT DEMOGRAPHICS DATA WAS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386748 ↗
• MalfunctionOct 22, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, DURING TESTING THE BALLOON OF THIS SWAN-GANZ CATHETER, IT COULD NOT BE INFLATED. ISSUE SOLVED BY REPLACED WITH NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND RUPTURED AT THE CENTRAL AREA; THE BALLOON EDGES DID NOT APPEAR TO MATCH UP AT THE RUPTURED REGION. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355414 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, DURING TESTING OF THIS SWAN-GANZ CATHETER, THE BALLOON LEAKED AND COULD NOT BE INFLATED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER PRODUCT EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA AND THE RUPTURED EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED LOCATION. PATIENT DEMOGRAPHIC DATA UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305685 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  AS REPORTED, DURING TESTING OF THIS SWAN-GANZ CATHETER, THE BALLOON DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND RUPTURED AT THE CENTRAL AREA. THE BALLOON EDGES DID NOT APPEAR TO MATCH UP AT THE RUPTURED REGION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297683 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CCO CATHETER, THE BALLOON BURST. THE BRAND/SIZE OF THE USED INTRODUCER IS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293894 ↗
• MalfunctionSep 15, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN A MITRAL CASE, THIS SWAN GANZ CATHETER TOOK A LONG TIME TO DISPLAY CARDIAC OUTPUT (CO) AND THEN IT WAS PROVIDED INTERMITTENTLY SINCE BLOOD TEMPERATURE WAS SWINGING AND OUT OF RANGE. THE CATHETER WAS STILL IN SITU IN PATIENT. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048695 ↗
• MalfunctionSep 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  AS REPORTED, AFTER USING THIS SWAN-GANZ CATHETER, THE CUSTOMER REALIZED THE DEVICE WAS EXPIRED. THE DEVICE WORKED EFFECTIVELY AND AS PRESCRIBED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993173 ↗
• MalfunctionSep 3, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING TESTING, THE BALLOON OF THIS SWAN-GANZ CATHETER LEAKED AND COULD NOT BE INFLATED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND RUPTURED AT THE CENTRAL AREA, BALLOON EDGES DID NOT MATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949941 ↗
• MalfunctionAug 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN TESTING PRIOR TO USE IN PATIENT, THE BALLOON OF THIS SWAN-GANZ CATHETER WAS DAMAGED AND DID NOT INFLATE. ANOTHER CATHETER WAS USED FOR THE PROCEDURE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922297 ↗
• MalfunctionAug 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BEFORE USE OF THE SWAN-GANZ CATHETER, THE BALLOON FAILED TO MAINTAIN ITS INFLATION. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907625 ↗
• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT, A SWAN-GANZ CATHETER HAD A BLOOD LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. THERE WAS NO ALLEGATION OF PATIENT INJURY. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856042 ↗
• MalfunctionAug 13, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, AFTER A LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT, THIS SWAN GANZ CATHETER PROVIDED INCORRECT MIXED VENOUS OXYGEN SATURATION (SV02) VALUE. THE HEMOSPHERE INDICATED AN SVO2 OF 84% WHILE THE GAS SHOWED 48%. AFTER THIS CALIBRATION, IT WAS A GOOD MEASUREMENT UNTIL THERE WAS SUDDENLY ANOTHER INCREASE TO 63%, WHILE THE GAS WAS AT 43%. NO ERROR MESSAGE WAS DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793391 ↗
• MalfunctionAug 13, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, IN A PATIENT WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED DUE TO A LEFT VENTRICLE FAILURE WHO UNDERWENT INTO A THORACIC SURGERY FOR AN EMPYEMA, THIS SWAN GANZ CATHETER PLACED FOR SUSPECTED OVERLOAD, 30 MINUTES AFTER CALIBRATION, PROVIDED INCORRECT MIXED VENOUS OXYGEN SATURATION (SV02) VALUE. WHEN CALIBRATED SHOWED A SVO2 OF 60% WHEREAS MONITOR GAVE A SVO2 OF 63% WHICH WAS ACCEPTABLE. HOWEVER AFTER 30 MINUTES, SV02 DROPPED FROM 60% TO 29%. THEREFORE, A BLOOD SAMPLE WAS TAKEN AND SHOWED A SV02 OF 59%. THE SWAN GANZ WAS RECALIBRATED AND THE SV02 WAS NORMAL AGAIN. NO ERROR MESSAGE WAS DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793164 ↗
• MalfunctionAug 7, 2025High Readings; High Readings

  AS REPORTED, WHEN THIS SWAN-GANZ CATHETER WAS CONNECTED TO THE PRESSURE TRANSDUCER WHICH WERE ZEROED, THE CATHETER PROVIDED INACCURATE CENTRAL VENOUS PRESSURE (CVP) AND PULMONARY ARTERY PRESSURE (PAP). THE EXPECTED VALUES WERE ZERO FOR BOTH CVP AND PAP, BUT THE DISPLAYED CVP AND PAP WERE 15 MMHG AND 60 MMHG, RESPECTIVELY, WHICH WERE HIGHER THAN EXPECTED. NO ERROR MESSAGE WAS DISPLAYED. THE CATHETER WAS UNDER ATMOSPHERIC PRESSURE AND HAD NOT YET BEEN INSERTED INTO THE PATIENT. NO INFORMATION WAS AVAILABLE REGARDING WAVEFORM, AND THERE WERE NO ALLEGATIONS OF OCCLUSION, LEAKAGE OR KINK IN THE DEVICE. THE ISSUE WAS NOT CONSIDERED TO BE RELATED TO THE PATIENT'S CONDITION. THE DEVICE LOGS WERE NOT AVAILABLE. WHEN THE CATHETER WAS REPLACED WITH A NEW ONE, IT WORKED WITHOUT PROBLEMS. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743006 ↗
• MalfunctionJun 4, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THIS SWAN GANZ CATHETER TEMPERATURE MEASUREMENT WAS TOO HIGH. THEREFORE, CARDIAC OUTPUT (CO) VALUE DISPLAYED WAS INCORRECT. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140283 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN USING THIS SWAN-GANZ CATHETER, THE ERROR MESSAGE'S FAULT: CO CHECK THERMAL FILAMENT POSITION AND FAULT: CO CATHETER VERIFICATION, USE BOLUS MODE WERE DISPLAYED ON THE MONITOR. THE MONITOR WAS CHECKED AND NO ISSUES WERE FOUND. DESPITE THE ALARMS, CARDIAC OUTPUT COULD BE MONITORED USING THE ICO THROUGH BOLUS MODE. AS PER PRODUCT EVALUATION FINDINGS, PROXIMAL THERMAL FILAMENT COVER HAD A TEAR AT THE JUNCTION BETWEEN THE COVER AND THE BOND. TORN EDGES OF THE COVER DID NOT APPEAR TO MATCH UP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068362 ↗

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-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-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