SWAN-GANZ CCOMBO VRecalls & reported problems across all models

We found 2 models of SWAN-GANZ CCOMBO V by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 133 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2021 and Sep 29, 2026 — classified as 2 deaths, 4 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (24 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SWAN-GANZ CCOMBO V recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 8, 2026Open, 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 · names 2 of these models · Recall details · FDA record ↗

2. Feb 14, 2023Open, 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 ↗

3. Feb 14, 2023Open, 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-1379-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported SWAN-GANZ CCOMBO V problems

SWAN-GANZ CCOMBO V models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SWAN-GANZ CCOMBO V 777F8

  CATHETER, FLOW DIRECTED
  2 recalls92 reports
• SWAN-GANZ CCOMBO V 774F75

  CATHETER, FLOW DIRECTED
  2 recalls2 deaths41 reports

Recent SWAN-GANZ CCOMBO V adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938627 ↗
• 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 18, 2026Difficult to Remove

  It was reported that during use of the Swan-Ganz catheter it was difficult to remove from the patient. The catheter became stuck in the introducer with 10 cm left. The catheter was eventually able to be removed without incident. The catheter was still intact once removed from the patient, however the surface was noted to "have bulging". There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820241 ↗
• 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 14, 2025Gas/Air Leak; Unintended Deflation

  SAN GANZ DEFLATED SLOWLY DURING INSERTION - AIR ESCAPES FROM BALLOON/ REMOVED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553824 ↗
• 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 20, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BEFORE USE OF THE SWAN-GANZ CATHETER, IT WOULD NOT SELF-DEFLATE EVEN THOUGH THE VALVE WAS TURNED ON AND OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336449 ↗

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