SWAN-GANZRecalls & reported problems across all models

We found 13 models of SWAN-GANZ by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Jan 15, 2020 and Sep 22, 2026 — classified as 2 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (60 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SWAN-GANZ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 8, 2026Open, 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-2204-2026 · Root cause: Process change control · Recall details · FDA record ↗

2. Apr 8, 2026Open, 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-2203-2026 · Root cause: Process change control · names 3 of these models · Recall details · FDA record ↗

3. Apr 8, 2026Open, 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 · names 3 of these models · Recall details · FDA record ↗

Most reported SWAN-GANZ problems

SWAN-GANZ models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SWAN-GANZ 131F7

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 recall13 reports
• SWAN-GANZ 131F7

  Catheter, Intravascular, Diagnostic
  1 recall2 reports
• Swan-Ganz AIQSGF8

  Catheter, Flow Directed
  1 recall1 report
• SWAN-GANZ D200F7

  ELECTRODE, PACEMAKER, TEMPORARY
  1 recall0 reports
• SWAN GANZ SGPT54

  Catheter, Oximeter, Fiber-Optic
  1 recall0 reports
• SWAN GANZ SGPT64P

  Catheter, Oximeter, Fiber-Optic
  1 recall0 reports
• SWAN-GANZ SGPT755P

  Catheter, Oximeter, Fiber-Optic
  1 recall0 reports
• SWAN-GANZ D97120F5

  CATHETER, FLOW DIRECTED
  46 reports
• SWAN-GANZ D97130F5

  CATHETER, FLOW DIRECTED
  36 reports
• SWAN-GANZ 70CC2

  COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
  4 reports
• SWAN-GANZ 110F5

  CATHETER, FLOW DIRECTED
  3 reports
• SWAN-GANZ HEMA70CC2

  Computer, Diagnostic, Programmable
  2 reports
• SWAN-GANZ 139F75

  Catheter, continuous flush
  1 report

Recent SWAN-GANZ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860162 ↗
• 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 ↗
• MalfunctionMar 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A NURSE FOUND BLOOD BACKING UP THROUGH THE BLUE PORT OF A SWAN GANZ CATHETER AND "THE END PIECE HAD FALLEN OFF". ISSUE OCCURRED POST PROCEDURE WHILE IN THE CRITICAL CARE UNIT AND WAS RESOLVED BY REMOVING THE LINE. CATHETER WAS INSIDE THE PATIENT FOR 8 DAYS. THERE WAS MINIMAL BLOOD LOSS BUT OVERALL, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691245 ↗
• MalfunctionJan 8, 2026Material Fragmentation

  AS REPORTED DURING USE THE SWAN GANZ CATHETER WAS TESTED BEFORE A CASE AND THE BALLOON INFLATED. IT INFLATED IN THE BODY AS WELL BUT ONCE IT WAS REMOVED THE BALLOON HAD ALREADY DEFLATED WITHOUT THE DOCTOR DOING SO., THEY TRIED TO INFLATE THE BALLOON AGAIN OUTSIDE THE BODY AND IT WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24015691 ↗
• MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, A CCO CABLE HAD LOW BLOOD TEMPERATURE READING AND COULD NOT CALCULATE CO. THE CCO CABLE HAD BLOOD TEMPERATURE OF 89 WHILE THE FOLEY CATHETER HAD 97. CABLE WAS CONNECTED TO AN ALTA MONITOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796392 ↗
• MalfunctionDec 8, 2025Contamination; Contamination

  AS REPORTED, DURING USE IN PATIENT, THE GUIDEWIRE DID NOT PASS THROUGH THIS SWAN-GANZ CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER ENGINEERING EVALUATION FINDINGS, CONTAMINATION WAS FOUND INSIDE THE FLUID PATH. THE MATERIAL OCCLUDING THE LUMEN SHOWED A COMPOSITIONAL MATCH OF 51.84% WITH CYCLOHEPTANE. THIS COMPONENT WAS VERIFIED AGAINST THE BILL OF MATERIAL (BOM) FOR THE CORRESPONDING SUBASSEMBLY AND IT WAS DETERMINED THAT THIS COMPONENT IS NOT PART OF THE AFFECTED PRODUCT. PATIENT DEMOGRAPHICS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749906 ↗
• 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 ↗
• MalfunctionAug 14, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING TEST OF THE BALLOON OF THIS SWAN GANZ CATHETER, THERE WAS A LEAKAGE. 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 22802714 ↗
• 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 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 ↗
• 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 ↗

Other Edwards Lifesciences LLC products

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• SAPIEN 3 Ultra System3 models · 876 reports
• FOGARTY32 models · 486 reports · 3 recalls