SWAN-GANZ PACING TD CATHETER D205F7Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00690103197334), received between Dec 4, 2023 and Aug 26, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (11 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Pacing Problem

  As reported, during use in patient, a Swan-Ganz Pacing TD catheter did not pace from the beginning of procedure. No further information was available. There was no allegation of patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455252 ↗
• MalfunctionAug 24, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421337 ↗
• MalfunctionAug 12, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223393 ↗
• MalfunctionAug 12, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222932 ↗
• MalfunctionFeb 27, 2026Pacing Problem

  AS REPORTED, DURING USE, A SWAN-GANZ PACING CATHETER DID NOT PACE WITH BOTH OF THE ATRIAL AND VENTRICULAR ELECTRODES. THE ERROR MESSAGE RELATED TO SHORT CONDITION WAS DISPLAYED ON THE MONITOR. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474638 ↗
• InjuryDec 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED IN AN ACADEMIC ARTICLE THAT DURING USE OF THE SWAN-GANZ CATHETER THE PATIENT'S TRICUSPID VALVE CHORDAE TENDINEAE RUPTURED. A 55 YEAR OLD MALE UNDERWENT TOTAL ARCH REPLACEMENT FOR STANFORD TYPE B AORTIC DISSECTION. PREOPERATIVELY, CARDIAC FUNCTION WAS PRESERVED AND VALVULAR REGURGITATION WAS TRIVIAL. IMMEDIATELY AFTER SURGERY, CHEST RADIOGRAPHY REVEALED THAT THE PAC WAS KINKED WITHIN THE PULMONARY ARTERY APPROXIMATELY 6 CM FROM THE TIP. THE CATHETER WAS WITHDRAWN UNDER RADIOGRAPHIC MONITORING, BUT THE KINK WAS NOT RESOLVED. IT WAS FURTHER WITHDRAWN TO A DEPTH OF 15 CM WHILE OBSERVING THE PRESSURE WAVEFORM, THEN ADVANCED AGAIN INTO THE PULMONARY ARTERY AFTER BALLOON INFLATION. SUBSEQUENT RADIOGRAPHY CONFIRMED THAT THE KINK HAD BEEN CORRECTED. THE POSTOPERATIVE COURSE WAS INITIALLY UNEVENTFUL HOWEVER, ON POSTOPERATIVE DAY 9, BODY WEIGHT GAIN WAS NOTED, AND ECHOCARDIOGRAPHY REVEALED NEW-ONSET SEVERE TRICUSPID REGURGITATION. ON POSTOPERATIVE DAY 15, TRICUSPID VALVE REPAIR WAS PERFORMED. INITIALLY, PER THE ARTICLE, IT IS HIGHLY LIKELY THAT WHEN THE KINKED PA CATHETER WAS WITHDRAWN INTO THE RIGHT ATRIUM, THE KINKED PORTION BECAME CAUGHT ON THE TRICUSPID VALVE CHORDAE TENDI

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23835474 ↗
• MalfunctionApr 25, 2025Pacing Problem; Pacing Problem

  AS REPORTED, AFTER CATHETER INSERTION IN PATIENT, A SWAN-GANZ PACING THERMODILUTION CATHETER DID NOT PACE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911282 ↗
• MalfunctionSep 30, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT VENTRICULAR PACING WAS UNABLE TO BE PERFORMED FROM THE BEGINNING OF USE AFTER THE CATHETER INSERTION. THE D205F7 CATHETER WAS REPOSITIONED BUT THE ISSUE PERSISTED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE FOLLOWING INFORMATION WAS UNABLE TO BE OBTAINED WHAT KIND OF SURGERY EXAMINATION THE CATHETER WAS USED FOR OR WHETHER THE PATIENT HAD CARDIAC CONDUCTION DEFECT. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340820 ↗
• MalfunctionSep 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE SWAN-GANZ PACING CATHETER WAS UNABLE TO PACE FROM THE BEGINNING OF USE AFTER INSERTION. NO PACING WAVEFORM OR SPIKE WERE DISPLAYED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE FOLLOWING INFORMATION WAS UNABLE TO BE OBTAINED: WHAT KIND OF SURGERY/EXAMINATION THE CATHETER WAS USED FOR OR WHETHER THE PATIENT HAD CARDIAC CONDUCTION DEFECT. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315593 ↗
• MalfunctionAug 14, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT APPROPRIATE PACING WAVEFORM WAS NOT DISPLAYED ON AN ELECTROCARDIOGRAM ECG USING A D205F7 SWAN GANZ PACING CATHETER AND IT WAS UNABLE TO PACE DURING USE. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING THE CATHETER. THE FOLLOWING INFORMATION WAS UNAVAILABLE THE PHASE WHEN THE CATHETER WAS UNABLE TO PACE WHAT KIND OF SURGERY EXAMINATION THE CATHETER WAS USED FOR WHETHER THE PATIENT HAD CARDIAC CONDUCTION DEFECT OR WHETHER THE CATHETER WAS REPLACED. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982509 ↗
• MalfunctionJul 24, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE D205F7 SWAN-GANZ PACING TD CATHETER WAS UNABLE TO PACE FROM THE BEGINNING OF USE AFTER CATHETER INSERTION. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE KIND OF SURGERY/EXAMINATION THE CATHETER WAS USED FOR OR WHETHER THE PATIENT HAD CARDIAC CONDUCTION DEFECT WAS UNABLE TO BE OBTAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822878 ↗
• MalfunctionDec 8, 2023No Pacing; No Pacing

  IT WAS REPORTED THAT DURING USE OF THIS PACING CATHETER, IT WAS UNABLE TO PACE. THIS WAS AFTER THE CATHETER INSERTION DURING A MINIMALLY INVASIVE CARDIAC SURGERY (MICS). THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. IT IS UNKNOWN WHETHER THE PATIENT HAD CARDIAC CONDUCTION DEFECT. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WAS NO MALFUNCTION REGARDING ATRIAL PACING REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293243 ↗
• MalfunctionDec 4, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT IT WAS UNABLE TO PACE DURING USE. THE FOLLOWING INFORMATION WAS UNAVAILABLE: BACKGROUND OF MALFUNCTION OCCURRENCE, THE PHASE WHEN THE CATHETER GOT UNABLE TO PACE, WHAT KIND OF SURGERY/EXAMINATION THE CATHETER WAS USED FOR, WHETHER THE PATIENT HAD CARDIAC CONDUCTION DEFECT OR WHETHER THE CATHETER WAS REPLACED. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258966 ↗