SWAN-GANZ D97130F5Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00690103150438), received between Feb 3, 2020 and Nov 26, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (23 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Pacing Problem; Pacing Problem

  AS REPORTED DURING USE IN A PATIENT AS BACKUP FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), THIS SWAN-GANZ PACING CATHETER DID NOT SENSE OR PACE FROM THE BEGINNING OF PROCEDURE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE BRAND/SIZE OF THE USED INTRODUCER WAS FROM TERUMO, 6FR. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660565 ↗
• MalfunctionSep 9, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE PACING CATHETER, IT WAS UNABLE TO PACE. THE TEAM TRIED NEW PACER BOXES AND REPLACED THE CABLES HOWEVER, THE CATHETER STILL DID NOT WORK. A NEW CATHETER WORKED AS EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008277 ↗
• MalfunctionAug 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A SWAN GANZ PACING CATHETER WAS MISSING AFTER IT WAS PULLED OUT OF THE RIGHT FEMORAL VEIN. THERE WAS NO PATIENT INJURY. CONTACT INFORMATION WAS NOT PROVIDED SO FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929357 ↗
• MalfunctionJul 29, 2025Pacing Problem; Pacing Problem

  AS REPORTED RIGHT AFTER INSERTION IN A PATIENT THIS SWAN GANZ PACING CATHETER DID NOT PACE AT ALL. WHEN THIS CATHETER WAS REPLACED THE PROBLEM WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22654666 ↗
• MalfunctionJun 4, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT, DURING USE IN A TAVR PROCEDURE, A SWAN GANZ CATHETER FAILED TO PACE. CATHETER WAS INSERTED THROUGH THE VENOUS SHEATH AND INTO THE RIGHT VENTRICLE. ALTHOUGH THE CATHETER WAS CONNECTED TO THE CONNECTOR AND TO THE PACER BOX, THE PACING FUNCTION COULD NOT TURN ON. CUSTOMER EXCHANGED THE CONNECTOR AND BOXES BUT ISSUE CONTINUED. A NEW CATHETER WAS USED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE PATIENT HAD ASYSTOLE AND HAD TO BE SUBCUTANEOUSLY PACED IN THE INTERM. NO ALLEGATIONS OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146395 ↗
• MalfunctionJun 4, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT, DURING USE IN A TAVR PROCEDURE, A SWAN GANZ CATHETER FAILED TO PACE. CATHETER WAS INSERTED THROUGH THE VENOUS SHEATH AND INTO THE RIGHT VENTRICLE. ALTHOUGH THE CATHETER WAS CONNECTED TO THE CONNECTOR AND TO THE PACER BOX, THE PACING FUNCTION COULD NOT TURN ON. CUSTOMER EXCHANGED THE CONNECTOR AND BOXES BUT ISSUE CONTINUED. A NEW CATHETER WAS USED TO RESOLVE THE ISSUE. NO ALLEGATIONS OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146335 ↗
• MalfunctionApr 3, 2025Pacing Problem; Pacing Problem

  AS REPORTED, WHEN TESTING BEFORE APPROACHING RIGHT CORONARY ARTERY PRIOR TO PERCUTANEOUS CORONARY INTERVENTION DUE TO CHRONIC TOTAL OCCLUSION, THIS SWAN-GANZ PACING CATHETER DID NOT CAPTURE. REPOSITIONING THE CATHETER ELECTRODES DID NOT SOLVE THE ISSUE. THE ISSUE WAS SOLVED REPLACING THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762508 ↗
• MalfunctionMar 27, 2025Pacing Problem; Pacing Problem

  AS REPORTED, JUST RIGHT AFTER INSERTION IN THE PATIENT, A SWAN-GANZ PACING CATHETER DID NOT PACE. WHEN THIS CATHETER WAS REPLACED, THE PROBLEM WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709537 ↗
• MalfunctionMar 17, 2025No Pacing; No Pacing

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A SWAN GANZ BIPOLAR PACING CATHETER. THE CLINICIAN STATED THAT IT WOULD NOT PACE DURING USE. THEY ATTEMPTED TO REPLACE THE MONITOR AND THE CABLE TO RESOLVE THE ISSUE. BUT THE ISSUE STILL CONTINUED. THE PROCEDURE BEING PERFORMED WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624862 ↗
• MalfunctionMar 6, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED DURING USE THAT THIS SWAN GANZ PACING CATHETER WOULD NOT CAPTURE. THE REMINGTON DISPOSABLE CABLES AND MEDTRONIC PACER BOX WAS CHANGED BUT THIS DID NOT RESOLVE THE ISSUE. THERE WAS NO HARM TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540085 ↗
• MalfunctionMar 6, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED DURING USE THAT THIS SWAN GANZ PACING CATHETER WOULD NOT CAPTURE. THE REMINGTON DISPOSABLE CABLES AND MEDTRONIC PACER BOX WAS CHANGED BUT THIS DID NOT RESOLVE THE ISSUE. THERE WAS NO HARM TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21539935 ↗
• MalfunctionFeb 18, 2025Pacing Problem; Pacing Problem

  EDWARDS LIFESCIENCES WAS NOTIFIED VIA A DIRECT VOLUNTARY INCIDENT REPORT SUBMISSION TO THE FDA THAT A PATIENT EXPERIENCED COMPLETE HEART BLOCK AFTER POST IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE. THERE WAS INTERMITTENT FAILURE OF THE TEMPORARY PACING WIRE LEADING TO SHORT PERIODS OF ASYSTOLE. THE TEMPORARY PACING WIRE WAS REPOSITIONED. SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO 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 21404335 ↗
• MalfunctionFeb 13, 2025Pacing Problem; Pacing Problem

  EDWARDS LIFESCIENCES WAS NOTIFIED VIA A DIRECT VOLUNTARY INCIDENT REPORT SUBMISSION TO THE FDA THAT A CUSTOMER EXPERIENCED, DURING EITHER A HYBRID OR TRANSCATHETER AORTIC CALVE REPLACEMENT IN AN ELDERLY FEMALE PATIENT, THE PACING CATHETER MALFUNCTION AND THE WIRES WERE "REMOVED INTACT." PER THE CUSTOMER, THE PACING WIRE MAY BE INTERNALLY SEVERED. THE CABLE IS BENT AND LOOKS TO BE BROKEN INTERNALLY. 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 21376553 ↗
• MalfunctionJan 8, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PE074F5 PACING CATHETER PIN CONNECTORS SHOULD HAVE BEEN LABELED AS DISTAL AND PROXIMAL RESPECTIVELY BUT BOTH WERE FOUND INCORRECTLY LABELED AS PROXIMAL DURING USE. THE CUSTOMER NOTICED THIS MALFUNCTION WHEN THE CUSTOMER TRIED TO REPOSITION THE CATHETER AFTER CONNECTING THE PIN CONNECTORS TO AN EXTERNAL PACEMAKER IN THE ICU AFTER CATHETER INSERTION. IT IS UNKNOWN IF THE PACING CATHETER PACED OR NOT. THE PATIENT SUFFERED FROM HEART FAILURE AND THE CATHETER WAS USED FOR IMPELLA OPERATION IN THE ICU. IT WAS UNKNOWN IF THE PATIENT HAD A CARDIAC CONDUCTION DEFECT. WHEN THE DEVICE WAS REPLACED THE PROBLEM WAS SOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT IS A 69 YEAR OLD MALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21104909 ↗
• MalfunctionOct 28, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE D97130F5 BIPOLAR PACING CATHETER WAS UNABLE TO PACE DURING USE. WHEN THE CATHETER WAS REPLACED, THE PROBLEM WAS SOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20548857 ↗
• MalfunctionOct 17, 2024No Pacing; No Pacing

  IT WAS REPORTED THAT THE SWAN GANZ BIPOLAR PACING CATHETER DID NOT PACE, DURING USE. ONLY LIMITED DETAILS WERE PROVIDED. THE EXACT DATE OF THE OCCURRENCE IS UNKNOWN. THERE WAS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE WAS NO REPORT OF INAPPROPRIATE PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472871 ↗
• MalfunctionOct 8, 2024Pacing Problem; No Pacing; Pacing Problem; No Pacing

  IT WAS REPORTED THAT THE SWAN GANZ BIPOLAR PACING CATHETER DID NOT PACE, DURING PATIENT USE. THE CATHETER WAS REPLACED AND THEN THE ISSUE WAS RESOLVED. THERE ARE LIMITED DETAILS AVAILABLE. DETAILS REGARDING LOT NUMBER, MALFUNCTION DETAILS, PROCEDURE TYPE, PATIENT DEMOGRAPHICS, ARE UNKNOWN. THERE WAS NO PATIENT HARM OR INJURY. THE DEVICE WAS DISCARDED BY THE HOSPITAL. THERE IS NO PRODUCT RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398255 ↗
• MalfunctionAug 9, 2024No Pacing; No Pacing

  IT WAS REPORTED THAT THE SWAN GANZ BIPOLAR PACING CATHETER DID NOT PACE, DURING USE. THERE WAS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE WAS NO REPORT OF INAPPROPRIATE PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951415 ↗
• MalfunctionAug 8, 2024

  BALLOON WOULD NOT INITIATE, NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR CATHETER, FLOW DIRECTED, SWAN-GANZ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937600 ↗
• MalfunctionJul 23, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE, D97130F5 SWAN-GANZ BIPOLAR PACING CATHETER FROM LOT 65369611, DID NOT CAPTURE. THE WIRE WAS INTRODUCED INTO THE RV UNDER FLUOROSCOPIC GUIDANCE. GOOD CAPTURE AND SENSING WAS CONFIRMED, BUT LOSS OF CAPTURE AND SENSING WAS NOTED SEVERAL MINUTES LATER, DESPITE UNCHANGED LEAD POSITION. THE SWAN-GANZ PACING CATHETER WAS REMOVED AND REPLACED WITH ANOTHER ONE. GOOD CAPTURE AND SENSING WAS CONFIRMED. LOSS OF CAPTURE AND SENSING WAS NOTED AGAIN SEVERAL MINUTES LATER, DESPITE UNCHANGED LEAD POSITION. THE EXTERNAL HARDWARE COMPONENTS (CONNECTING CABLE AND TEMPORARY PM BOX) WERE REPLACED BUT AGAIN SHOWED EXIT BLOCK AND NO SENSING, SUGGESTING FAILURE OF THE SWAN-GANZ CATHETER LEAD AGAIN. THE CATHETER WAS REMOVED AND THE PHYSICIAN ELECTED TO PLACE PERMANENT PACEMAKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805566 ↗
• MalfunctionJul 16, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THIS D97130F5 SWAN-GANZ BIPOLAR PACING CATHETER WOULD NOT CAPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756878 ↗
• MalfunctionMay 13, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE, THE D97130F5 SWAN-GANZ PACING CATHETER FROM LOT 65419175 WOULD NOT CAPTURE OR WORK FOR PACING. THEY HAD TO OPEN ANOTHER BOX WHICH ENDED UP WORKING THAT TIME. NO PATIENT HARM. IT IS UNCLEAR IF THE DEVICES ARE AVAILABLE FOR RETURN. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305103 ↗
• MalfunctionMay 13, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE, THE D97130F5 SWAN-GANZ PACING CATHETER FROM LOT 65312604 WOULD NOT CAPTURE OR WORK FOR PACING. THEY HAD TO OPEN ANOTHER BOX WHICH ENDED UP WORKING THAT TIME. NO PATIENT HARM. IT IS UNCLEAR IF THE DEVICE IS AVAILABLE FOR RETURN. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19304916 ↗
• MalfunctionMar 20, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED IN MEDWATCH (B)(4) THAT THERE WAS A FAILURE WITH THE SWAN GANZ BIPOLAR PACING CATHETER, DURING USE. THE CUSTOMER STATES THE CATHETER WOULD NOT PACE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946507 ↗
• MalfunctionMar 1, 2024

  ELDERLY MALE WITH CORONARY ARTERY DISEASE. PROCEDURE: TRANSCATHETER AORTIC VALVE REPLACEMENT. SWAN-GANZ PACING CATHETER WAS PLACED IN THE PATIENT, WHEN TURNED ON IT WOULD NOT CAPTURE. SWAN-GANZ REMOVED AND ANOTHER ONE USED WITHOUT ISSUES. NO KNOWN PATIENT HARM. MANUFACTURER RESPONSE FOR CATHETER, FLOW DIRECTED, SWAN-GANZ (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815515 ↗

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;