SWAN-GANZ TRUE SIZE 123F6Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00690103000375), received between Oct 22, 2021 and Apr 30, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (8 reports).

4 other recalls cover devices cleared under the same FDA submission (K160084); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Deflation Problem; Deflation Problem

  AS REPORTED, DURING TESTING THIS SWAN GANZ CATHETER, THE BALLOON DID NOT DEFLATE SINCE THE VALVE WAS NOT RELEASING. THE ISSUE WAS SOLVED REPLACING THE CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932687 ↗
• MalfunctionOct 3, 2024Burst Container or Vessel; Burst Container or Vessel

  PER REPORT RECEIVED FROM AUSTRIA, WHILE TRYING TO INFLATE THE BALLOON WITH AIR AND INJECT CONTRAST MEDIA FOR A SECOND TIME DURING A CRT (CARDIAC RESYNCHRONIZATION THERAPY) PACEMAKER PROCEDURE, THE BALLOON OF THIS SWAN-GANZ CATHETER BURST AND A SMALL PIECE OF THE BALLOON WAS MISSING; THEREFORE, IT DID NOT INFLATE ANYMORE. THE CATHETER WAS WITHDRAWN; THE REMAINING BALLOON WAS CONFIRMED TO BE ATTACHED TO THE CATHETER BODY. THEN, THE INSERTION CATHETER WAS FLUSHED, AND THE BALLOON MISSING PIECE WAS SEARCHED IN THE WORKING AREA WITHOUT SUCCESS. THE DEVICE HAD BEEN TESTED PRIOR TO USE CORRECTLY. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS HAVE BEEN REQUESTED. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359087 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PACKAGING ON THIS SWAN-GANZ CATHETER WAS OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015319 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PACKAGING ON THIS SWAN-GANZ CATHETER WAS OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015295 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE, THE PACKAGING ON THIS SWAN-GANZ CATHETER WAS OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015260 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE PACKAGING ON THESE 2 SWAN-GANZ CATHETERS FROM THE SAME LOT NUMBER WERE OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015231 ↗
• MalfunctionApr 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE, THE PACKAGING ON THESE 5 SWAN-GANZ CATHETERS FROM THE SAME LOT NUMBER WERE OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015185 ↗
• MalfunctionApr 4, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE, THE PACKAGING ON THIS SWAN-GANZ CATHETER WAS OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002374 ↗
• MalfunctionApr 4, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE, THE PACKAGING ON THIS SWAN-GANZ CATHETER WAS OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002220 ↗
• MalfunctionApr 4, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE, THE PACKAGING ON THIS SWAN-GANZ CATHETER WAS OBSERVED TO HAVE PUNCTURE-LIKE HOLES AND WHAT LOOKS LIKE CONDENSATION MARKS. IMAGES WERE PROVIDED BY THE CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER SHARED THAT THERE WERE MULTIPLE DEVICES THAT HAD THE SAME ISSUE. AS A RESULT OF THE ISSUE FOUND, THE CUSTOMER PULLED THEIR MODEL 123F6P AND 110F5 SWAN-GANZ CATHETERS AND INSPECTED THEM ALL FOR HOLES IN THE PACKAGING. THE ISSUE WAS RESOLVED BY SWITCHING TO A NON-EDWARDS BRAND PULMONARY ARTERY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002114 ↗
• MalfunctionOct 22, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE. THIS WAS BEFORE USE IN A PATIENT, DURING DEVICE PREP. THE NURSE TRIED TO DEFLATE THE BALLOON AFTER DETACHING THE SYRINGE, BUT IT WOULD NOT DEFLATE COMPLETELY. SHE INFLATED IT AGAIN AND REMOVED THE SYRINGE, BUT IT WOULD STILL NOT DEFLATE. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685865 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160084. One submission often covers many models, so check the product and lot details in each record.

• Z-0764-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly de
• Z-0765-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly dete
• Z-0763-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians
• Z-0762-2019 · Dec 21, 2018 · Terminated
  Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly det