SWAN-GANZ D97120F5Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00690103150421), received between Mar 28, 2022 and Sep 16, 2026 — classified as 2 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (37 reports).

1 other recall cover devices cleared under the same FDA submission (K233983, K822723); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793481 ↗
• MalfunctionSep 11, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742346 ↗
• MalfunctionAug 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING USE, THE ELECTRODES OF A SWAN GANZ PACING CATHETER GOT STUCK IN A 3RD PARTY SHEATH. PATIENT WITH A RIGHT INTRAJUGULAR TEMPORARY WIRE IN PLACE CAME TO THE ELECTROPHYSIOLOGY LAB FOR A DEVICE PLACEMENT. AFTER THE PACEMAKER PROCEDURE WAS COMPLETED, TEMPORARY WIRE WAS PULLED UNDER FLUOROSCOPY. AFTER UNLOCKING THE VALVE OF THE SHEATH, THE WIRE WAS BEING PULLED WHILE LEAVING THE SHEATH IN PLACE. AS THE TEMPORARY WIRE WAS CLOSE TO EXITING THE SHEATH, RESISTANCE WAS FELT AND PROMPTED THE STAFF TO PULL SLIGHTLY HARDER. THIS CAUSED THE ELECTRODES TO BREAK OFF. TO PREVENT IT FROM MIGRATING INTO THE PATIENT'S CIRCULATORY SYSTEM, STAFF GRABBED A 10CC SYRINGE AND PULLED THE BLOOD BACK INTO THE SIDE PORT THEN IMMEDIATELY PULLED THE SHEATH TO REMOVE IT FROM THE PATIENT. WHILE PRESSURE WAS PLACED ON THE INTRAJUGULAR SITE, THE CIRCULATING NURSE BEGAN INSPECTING THE SHEATH. THE NURSE CUT THE SHEATH OPEN AND WAS ABLE TO FIND THE ELECTRODE PORTION OF THE WIRE ADHERED TO THE LOCKING PORTION OF THE SHEATH. HOWEVER, THE NURSE WAS NOT ABLE TO REMOVE IT AS IT WAS STUCK. THE PHYSICIAN ALSO VISUALLY INSPECTED IT AND CONFIRMED THAT NOTHING WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22746640 ↗
• MalfunctionJul 18, 2025Pacing Problem; Pacing Problem

  AS REPORTED, DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION, A SWAN-GANZ PACING CATHETER COULD NOT PACE. DISTRIBUTION CABLES FOR THE PACEMAKER WERE CHANGED SEVERAL TIMES, BUT ISSUE CONTINUED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22548008 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE PACER CATHETER THERE WAS RESISTANCE. AFTER THE PERMANENT DEVICE WAS IMPLANTED, THE TECHNOLOGIST PROCEEDED TO PULL THE TEMPORARY DEVICE UNDER FLUORO. FOLLOWING GUIDELINES FOR REMOVAL OF THIS DEVICE, BY UNSCREWING TO UNLOCK THE VALVE OF THE SHEATH, PULLING THE WIRE BACK WHILE LEAVING THE SHEATH IN PLACE, THE TECH FELT RESISTANCE. THE TIP OF THE WIRE THAT CONTAINS THE ELECTRODES BROKE DURING THIS PULLBACK. THE TEAM WAS SUCCESSFUL IN REMOVING THE BROKEN WIRE, BUT DID OPEN THE SHEATH TO FIND THE BROKEN WIRE AND ELECTRODES. THE TEAM USED A 10CC SYRINGE TO DRAW BACK USING THE SIDE PORT WITH BLOOD RETURN TO PREVENT THE ELECTRODES AND TIP OF WIRE FROM MIGRATING INTO PATIENTS' CIRCULATORY SYSTEM. WIRE AND ELECTRODES WERE ACCOUNTED FOR WITHIN THE SHEATH WHEN TEAM OPENED UP SHEATH AFTER REMOVAL. SHEATH WAS IMMEDIATELY PULLED ONCE PRESSURE WAS ACHIEVED FROM THE SIDE PORT VIA THE 10-CC SYRINGE CONFIRMING ELECTRODES PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494130 ↗
• MalfunctionJun 19, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER DID NOT CAPTURE APPROPRIATELY. ISSUE OCCURRED IN THE CATH LAB. THERE WAS NO PATIENT HARM AND ISSUE DID NOT CAUSE A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290191 ↗
• InjuryJun 5, 2025Pacing Problem; Pacing Problem

  AS REPORTED, IN PATIENT WITH HIGH-GRADE AV BLOCK ASSOCIATED WITH SYNCOPE TREATED WITH ISOPROTERENOL AND REQUIRING TEMPORARY PACING, THIS SWAN GANZ PACING CATHETER DID NOT PACE WHEN IT WAS CONNECTED TO THE EXTERNAL PACING BOX. THE CATHETER HAD BEEN INSERTED AS PER PROCEDURE AND ALL OUTPUT SETTINGS WERE APPROPRIATE. MULTIPLE TROUBLESHOOTING STEPS WERE UNDERTAKEN, INCLUDING CHECKING CONNECTIONS, REPLACING THE PACER BOX, FLUSHING THE LINE AND CONFIRMING PLACEMENT BY MULTIPLE PHYSICIANS WITHOUT SUCCESS. A NEW CATHETER OF THE SAME MODEL WAS THEN INSERTED, WHICH FUNCTIONED NORMALLY. THERE WAS NO ALLEGATION OF PATIENT INJURY; PROCEDURE WAS PROLONGED AS MULTIPLE PHYSICIANS ATTEMPTED TO TROUBLESHOOT MALFUNCTIONING WIRE. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148227 ↗
• MalfunctionMar 14, 2025Pacing Problem; Pacing Problem

  AS REPORTED, DURING DEVICE PREPARATION IN A TAVI PROCEDURE, THE OVERPACING FUNCTION OF THIS SWAN-GANZ PACING CATHETER DID NOT WORK. THE ISSUE WAS SOLVED BY REPLACING THE CATHETER. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINEDTHE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603505 ↗
• MalfunctionMar 14, 2025Pacing Problem; Pacing Problem

  AS REPORTED, DURING DEVICE PREPARATION IN A TAVI PROCEDURE, THE OVERPACING FUNCTION OF THIS SWAN-GANZ PACING CATHETER DID NOT WORK. THE ISSUE WAS SOLVED BY REPLACING THE CATHETER. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603504 ↗
• MalfunctionMar 14, 2025Pacing Problem; Pacing Problem

  AS REPORTED, DURING DEVICE PREPARATION IN A TAVI PROCEDURE, THE OVERPACING FUNCTION OF THIS SWAN-GANZ PACING CATHETER DID NOT WORK. THE ISSUE WAS SOLVED BY REPLACING THE CATHETER. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603503 ↗
• MalfunctionMar 14, 2025Pacing Problem; Pacing Problem

  AS REPORTED, DURING DEVICE PREPARATION IN A TAVI PROCEDURE, THE OVERPACING FUNCTION OF THIS SWAN-GANZ PACING CATHETER DID NOT WORK. THE ISSUE WAS SOLVED BY REPLACING THE CATHETER. PATIENTS DEMOGRAPHICS WERE UNABLE TO BE OBTAINED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603500 ↗
• MalfunctionMar 6, 2025Pacing Problem; Pacing Problem

  AS REPORTED, DURING A TAVI PROCEDURE, THIS SWAN-GANZ PACING CATHETER (2025-03948-01) WAS CORRECTLY PLACED IN THE RIGHT VENTRICLE, HOWEVER, IT WAS IMPOSSIBLE TO GENERATE AN ELECTRICAL SIGNAL TO STIMULATE THE HEART. AS TROUBLESHOOTING, DIFFERENT CONNECTIONS WERE TRIED WITHOUT SUCCESS. THE DEVICE WAS REPLACE WITH ANOTHER ONE BUT THE SAME ISSUE OCCURRED (2025-03948-02). A THIRD CATHETER WITHOUT BALLOON WAS USED SUCCESSFULLY. AS PER CUSTOMER'S OPINION, THIS WAS A MANUFACTURING DEFECT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537039 ↗
• MalfunctionMar 6, 2025Pacing Problem; Pacing Problem

  AS REPORTED, DURING A TAVI PROCEDURE, THIS SWAN-GANZ PACING CATHETER (MANUFACTURER REFERENCE NUMBER (B)(4)) WAS CORRECTLY PLACED IN THE RIGHT VENTRICLE, HOWEVER, IT WAS IMPOSSIBLE TO GENERATE AN ELECTRICAL SIGNAL TO STIMULATE THE HEART. AS TROUBLESHOOTING, DIFFERENT CONNECTIONS WERE TRIED WITHOUT SUCCESS. THE DEVICE WAS REPLACE WITH ANOTHER ONE BUT THE SAME ISSUE OCCURRED (MANUFACTURER REFERENCE NUMBER (B)(4)). A THIRD CATHETER WITHOUT BALLOON WAS USED SUCCESSFULLY. AS PER CUSTOMER'S OPINION, THIS WAS A MANUFACTURING DEFECT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536642 ↗
• MalfunctionOct 16, 2024Pacing Problem; Pacing Problem

  AS REPORTED, AFTER INSERTION OF THIS BIPOLAR PACING SWAN-GANZ CATHETER, IT DID NOT SENSE. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459424 ↗
• MalfunctionSep 19, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A SWAN GANZ CATHETER WAS UNABLE TO PACE BEFORE USE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. INFORMATION INCLUDING KIND OF SURGERY/EXAMINATION THE CATHETER WAS USED FOR AND IF THE PATIENT HAD CARDIAC CONDUCTION DEFECT WAS UNKNOWN. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256937 ↗
• MalfunctionSep 13, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A D97120F5 COULD NOT CAPTURE DURING A MICRA CASE. STAFF TRIED PUTTING THE CATHETER IN, BUT IT FAILED TO CAPTURE. THE TEMPORARY PACER BOX WAS EXCHANGED BUT ISSUE CONTINUED. ISSUE WAS RESOLVED BY USING A NEW CATHETER. THERE WERE NO PATIENT INJURIES. INTRODUCER INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216280 ↗
• MalfunctionSep 10, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING PATIENT USE THERE WAS A SWAN GANZ BIPOLAR PACING CATHETER THAT DID NOT PACE. THE PATIENT'S HEART RATE WAS IN THE 20'S AND THE PACING CATHETER WOULD NOT CAPTURE. THERE WAS NO PATIENT INJURY. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185632 ↗
• MalfunctionSep 10, 2024Pacing Problem; Pacing Problem

  AS REPORTED, AFTER PLACING INTO THE PATIENT, THIS SWAN-GANZ PACING CATHETER DID NOT PACE. THE ISSUE WAS SOLVED REPLACING WITH A NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179938 ↗
• MalfunctionAug 27, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THIS SWAN-GANZ BIPOLAR PACING CATHETER IT WAS UNABLE TO PACE. AFTER CATHETER INSERTION, PACING WAS ATTEMPTED BUT IT DID NOT WORK. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. INFORMATION INCLUDING KIND OF SURGERY OR EXAMINATION THE CATHETER WAS USED FOR AND IF THE PATIENT HAD CARDIAC CONDUCTION DEFECT WAS UNKNOWN. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078805 ↗
• MalfunctionAug 27, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THIS SWAN-GANZ BIPOLAR PACING CATHETER, IT WAS UNABLE TO PACE. AFTER CONNECTING THE DISTAL AND PROXIMAL ELECTRODE CABLES, PACING WAS ATTEMPTED BUT IT DID NOT WORK. THE CUSTOMER READJUSTED THE CATHETER POSITION, BUT THE PROBLEM PERSISTED. THE PROBLEM WAS SOLVED AFTER REPLACING THE CATHETER. PATIENT DEMOGRAPHIC WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078754 ↗
• MalfunctionAug 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THERE WAS AN ISSUE WITH A D97120F5 BIPOLAR PACING CATHETER. THE RIGHT FEMORAL VEIN WAS ACCESSED, THEY GAVE A CURL TO THE CATHETER THEN ADVANCED THE PACING CATHETER TO THE RIGHT VENTRICLE WALL. ATTEMPTS TO TEST THE CATHETER USING THE STANDARD TEMPORARY PACEMAKER FAILED TO CAPTURE OR SEE ANY SPIKES ON THE ELECTROCARDIOGRAM (ECG). THE PACER BOX WAS SWITCHED OUT WITHOUT CHANGE. THE ELECTRICAL CABLES WERE SWITCHED OUT WITHOUT CHANGE. FINALLY, A NEW EDWARDS PACING CATHETER WAS OPENED, USED, AND FINALLY WORKED. THIS CAUSED A DELAY IN TAVR PROCEDURE TIME, BUT NO INJURY REPORTED. NO LOT NUMBER WAS PROVIDED. THE PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912121 ↗
• MalfunctionAug 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THERE WAS AN ISSUE WITH A D97120F5 BIPOLAR PACING CATHETER. THE RIGHT FEMORAL VEIN WAS ACCESSED, THEY GAVE A CURL TO THE CATHETER THEN ADVANCED THE PACING CATHETER TO THE RIGHT VENTRICLE WALL. ATTEMPTS TO TEST THE CATHETER USING THE STANDARD TEMPORARY PACEMAKER FAILED TO CAPTURE OR SEE ANY SPIKES ON THE ELECTROCARDIOGRAM (ECG). THE PACER BOX WAS SWITCHED OUT WITHOUT CHANGE. THE ELECTRICAL CABLES WERE SWITCHED OUT WITHOUT CHANGE. FINALLY, A NEW EDWARDS PACING CATHETER WAS OPENED, USED, AND FINALLY WORKED. THIS CAUSED A DELAY IN TAVR PROCEDURE TIME, BUT NO INJURY REPORTED. NO LOT NUMBER WAS PROVIDED. THE PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911888 ↗
• MalfunctionAug 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING A TAVR CASE, THE D97120F5 SWAN-GANZ PACING CATHETER DID NOT PACE. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911770 ↗
• MalfunctionJul 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A SWAN GANZ CATHETER COULD NOT PACE. SITE REPLACED EVERYTHING BEFORE OPENING A NEW SWAN, WHICH RESOLVED THE ISSUE. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840063 ↗
• MalfunctionJul 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A SWAN GANZ CATHETER, LOT 65515921, WOULD NOT CAPTURE. PACER BOX, CABLE, AND RED PINS WERE REPLACED, BUT ISSUE CONTINUED. SITE HAD TO REPLACE THE CATHETER TO RESOLVE THE ISSUE. THERE WERE NO PATIENT INJURIES AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233983, K822723. One submission often covers many models, so check the product and lot details in each record.

• Z-2204-2026 · Apr 8, 2026 · Open, Classified
  Swan-Ganz Pacing Catheter, Models: D200F7;