SWAN-GANZ CCOMBO V 777F8 (UDI 00690103146554)Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00690103146554), received between Mar 17, 2021 and Sep 29, 2026 — classified as 3 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (22 reports).

2 FDA recall records name this device's identifier, 2 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, 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-1379-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 15, 2025Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  AS REPORTED, DURING PREPARATION OF THE EQUIPMENT FOR A RIGHT HEART CATHETERIZATION IN PNEUMONOLOGY, THE BALLOON OF THIS SWAN-GANZ CATHETER BURST DURING TESTING WHEN INFLATED IN A CONTAINER OF 0.9% NACL, ACCORDING TO THE USUAL PROCEDURE. THE DEVICE WAS REPLACED IMMEDIATELY AND THE PROCEDURE CONTINUED WITHOUT ANY CLINICAL IMPACT ON THE PATIENT. 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277729 ↗
• MalfunctionSep 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THIS SWAN-GANZ CATHETER, THE NUMBERS WERE SUSPECTED OF BEING INACCURATE. THE DEVICE WAS ZEROED CORRECTLY. THE SUSPECT DEVICE WAS SWITCHED OUT FOR A NEW ONE AND EVERYTHING WORKED AS EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080046 ↗
• MalfunctionSep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED BEFORE USE THE SWAN GANZ CATHETER BALLOON WOULDN'T INFLATE WHEN THEY WERE CHECKING AT PRE INSERTION. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22971841 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  AS REPORTED, BEFORE USE IN THE PATIENT, THE BALLOON OF A SWAN-GANZ CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948019 ↗
• MalfunctionAug 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT BEFORE USE OF THIS SWAN-GANZ CATHETER, IT WAS FOUND THAT THE BALLOON WAS MISSING. THE LATEX PART WAS ONLY AROUND THE TIP OF THE CATHETER. WHEN IT WAS TRIED TO INFLATE THERE WAS NO BALLOON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922319 ↗
• MalfunctionAug 20, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT, DURING DEVICE PREP, THE BALLOON OF A SWAN GANZ CATHETER COULD NOT DEFLATE EVEN WHEN THE SYRINGE WAS PULLED BACK. IT WAS ALSO NOTED THAT THERE WAS PERFORATION AT THE TIP OF THE CATHETER. ISSUE WAS RESOLVED BY USING A NEW KIT. NO PATIENT INVOLVEMENT BUT ISSUE CAUSED DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857190 ↗
• MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE CATHETER, THE CUSTOMER HAS BEEN HAVING ISSUES WITH THEIR ARTERIAL LINE READINGS. PER THE CUSTOMER, AFTER A DAY OR TWO, THE DIASTOLIC READING SEEMS TO SIGNIFICANTLY DECREASE. THEY ESTIMATE THAT THE READINGS ARE NOT ACCURATE APPROXIMATELY EIGHTY PERCENT OF THE TIME. TO ACCOUNT FOR THE INACCURATE VALUES THE CUSTOMER HAS MOVED TO ADDING CUFFS BACK TO VALIDATE MEASUREMENTS AS WELL AS USING SYSTOLIC BP AS TARGETS FOR HYPOTENSIVE PATIENTS, INSTEAD OF MAP. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771436 ↗
• MalfunctionAug 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, BEFORE USE IN PATIENT, THE BALLOON OF THE SWAN-GANZ CATHETER DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745470 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE CATHETER, DURING A CRITICALLY LOW BLOOD GLUCOSE EVENT, THE PATIENT'S MAC INTRODUCER/ PA CATHETER APPEARED TO BE LEAKING. WHEN THE LINE WAS FLUSHED, FLUIDS BEGAN TO POUR OUT FROM SOMEWHERE IN THE INTRODUCER/ CANNULA. UNABLE TO GIVE PATIENT MEDICATIONS THROUGH CENTRAL ACCESS. HAD TO GIVE D50, AND SEVERAL INOTROPES, PRESSORS, AND SEDATION THROUGH PERIPHERAL IVS. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702022 ↗
• MalfunctionAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE CATHETER, IN A PATIENT THAT WAS ADMITTED WITH DECOMPENSATED HEART FAILURE, WITH CONCERN FOR CARDIOGENIC SHOCK, THERE WAS A FAST ESCALATION OF PRESSORS AFTER A COMPLICATED BEDSIDE SWAN GANZ CATHETER PLACEMENT. PER THE CUSTOMER "A DROP IN H&H FOLLOWED. SHOCK CALL WAS NOT DONE IN THE PATIENT WHO WAS FULL CODE. NO BEDSIDE ECHO WAS DONE TO RULE PERICARDIAL EFFUSION WITH DROP IN H&H. UNSUPERVISED SWAN PLACEMENT BY FELLOW WAS INITIALLY PERFORMED." THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702018 ↗
• MalfunctionJul 11, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED DURING USE THE SWAN GANZ CATHETER BALLOON WAS ABLE TO INFLATE BUT THEY COULD NOT GET IT TO DEFLATE. THEY HAD TO ACTUALLY PULL IT BACK OUT WHICH MADE IT POP. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480492 ↗
• MalfunctionJul 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER THE TEMPERATURE VALUE WAS NOT CONSISTENT, IT FLUCTUATED BETWEEN 30 C AND 48 C AND CAUSED THE CO VALUES TO STOP RUNNING. WHEN THE CATHETER HAD CONSISTENT PRESSURE ON THE PORT IT SEEMED TO WORK, HOWEVER WHEN THE CATHETER IS MOVED THE VALUES BECAME INCONSISTENT AND CO VALUES NO LONGER APPEARED. TROUBLESHOOTING INCLUDED USING A NEW CO CABLE AND CCO CABLE TEST. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391818 ↗
• MalfunctionJun 26, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED, DURING THE TEST OF THIS SAWN GANZ CATHETER, THE BALLOON COULD NOT BE DEFLATED AFTER OPENING THE GATE VALVE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334466 ↗
• MalfunctionJun 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, DURING USE IN PATIENT, A SWAN-GANZ CATHETER PROVIDED INACCURATE VALUES OF CONTINUOUS CARDIAC OUTPUT (9-10L/MIN) AND CARDIAC INDEX. CATHETER WAS NOT REPLACED. IT WAS DETERMINED BY THE CUSTOMER THAT THE CATHETER WAS THE CAUSE OF THE ISSUE AFTER TROUBLESHOOTING. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248377 ↗
• InjuryJun 11, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING TESTING, THE BALLOON OF THIS SWAN GANZ CATHETER LEAKED AND COULD NOT INFLATE. THE DEVICE WAS NOT USED ON PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER PRODUCT EVALUATION, THE BALLOON WAS FOUND TO BE RUPTURED IN THE CENTRAL AREA AND THE EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182548 ↗
• MalfunctionJun 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BEFORE USE IN A PATIENT THE BALLOON OF THIS SWAN GANZ CATHETER DETACHED WHEN THE CATHETER WAS ADVANCED INTO THE CONTAMINATION SHIELD OF THE TELEFLEX 9F INTRODUCER. THE FRAGMENTS OF THE BALLOON REMAINED IN THE INNER TUBE OF THE CONTAMINATION SHIELD. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128077 ↗
• MalfunctionMay 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, BEFORE USE, THE BALLOON OF A SWAN GANZ CATHETER BROKE AND COULD NOT CALIBRATE. A NEW CATHETER WAS OPENED TO RESOLVE THE ISSUE. THERE WERE NO ALLEGATIONS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040425 ↗
• MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED DURING USE WITH A SWAN GANZ CATHETER THE PROXIMAL INFUSION LUMEN HUB WAS FOUND DETACHED. THIS WAS AFTER CARDIAC SURGERY IN THE ICU. THE DETACHMENT WAS NOT CONFIRMED DURING SURGERY. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003544 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SWAN GANZ CATHETER WAS SEWN INTO A PATIENT'S HEART DURING A MITRAL VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFT X2. INITIALLY, THE PHYSICIAN REPORTED TO THE CLINICAL FIELD REPRESENTATIVE (REP) THAT BLOOD WAS LEAKING FROM THE SVO2. UPON OPENING THE DOOR OF THE CABLE, BLOOD WAS SEEN DRIPPING FROM THE FIBEROPTIC CABLE. THE REP REQUESTED FOR THE PHYSICIAN TO REMOVE THE SWAN GANZ CATHETER AND KEEP IT FOR EVALUATION. AFTER CATHETER REMOVAL, THE PHYSICIAN REPORTED BACK TO REP THAT THE BLOOD LEAKAGE WAS CAUSED BY THE SURGEON SEWING THE CATHETER INTO THE PATIENT. PHYSICIAN REPORTED THAT AFTER TWO PHYSICIANS COULDN'T REMOVE THE CATHETER, THE SURGEON "YANKED THE SEWN IN SWAN FROM THE PATIENT, SUBSEQUENTLY SHREDDING IT". THERE WAS NO MALFUNCTION WITH THE SWAN. NO IMAGING WAS DONE WHEN RESISTANCE WAS FELT WHILE REMOVING THE CATHETER. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THE PATIENT RECOVERED IN THE ICU AND MOVED TO STEP DOWN UNIT ON POST-OP DAY 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715209 ↗
• MalfunctionFeb 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT VASOPRESSER MEDICATION BACKED UP TO THE VIP PORT OF A SWAN GANZ CATHETER INTO THE SWANDOM AND ONTO THE BEDSHEETS, AFTER PATIENT WAS TRANSFERRED TO ICU. IT WAS DETERMINED THAT THE CATHETER WAS CURLED IN THE RV AND NEEDED TO BE REPLACED. A KINK AT THE THERMAL COIL WAS NOTICED AFTER REMOVAL OF CATHETER. THE CLINICIAN ASSUMED THAT THE KINK OCCLUDED THE VIP LUMEN WHICH PREVENTED THE PRESSERS FROM PASSING THROUGH. CATHETER WAS CHECKED PRIOR TO INSERTION AND NO DEFECTS WERE FOUND. IT WAS NOTED THAT ANESTHESIA HAD DIFFICULTY PLACING THE CATHETER IN THE OR AND TOOK THE TEAM SEVERAL ATTEMPTS TO SUCCESSFULLY PLACE IT. CATHETER WAS REPLACED SUCCESSFULLY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446919 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EDWARDS LIFESCIENCES WAS NOTIFIED VIA A DIRECT VOLUNTARY INCIDENT REPORT SUBMISSION TO THE FDA THAT A CUSTOMER EXPERIENCED, DURING USE OF THE SWAN-GANZ CATHETER, LEAKAGE THROUGH THE WHITE PORT. THE PATIENT HAD MEDICATION INFUSING THROUGH THIS PORT. THE PATIENT REQUIRED A NEW CATHETER TO BE PLACED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE VOLUNTARY INCIDENT REPORT DID NOT INCLUDE CUSTOMER CONTACT INFORMATION, PATIENT INFORMATION OR PRODUCT INFORMATION RELATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376560 ↗