SWAN-GANZ 131F7 (REF 131F7P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00690103000405), received between Aug 19, 2020 and Mar 25, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

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-2202-2026 · Root cause: Process change control · Recall details · FDA record ↗

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.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 18, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT BEFORE USE, THAT THERE WAS A HUB DISCONNECTION ON THE SWAN GANZ TRUE SIZE CATHETER. THE BLUE TUBING ON THE CATHETER BECAME SEPARATED FROM THE WHITE PORT CONNECTOR. THE FACILITY REPORTED THAT THIS OCCURRED THREE TIMES IN THE LAST SEVERAL WEEKS BUT WAS UNABLE TO GIVE EXACT DAYS OF OCCURRENCE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866106 ↗
• MalfunctionApr 18, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT BEFORE USE, THAT THERE WAS A HUB DISCONNECTION ON THE SWAN GANZ TRUE SIZE CATHETER. THE BLUE TUBING ON THE CATHETER BECAME SEPARATED FROM THE WHITE PORT CONNECTOR. THE FACILITY REPORTED THAT THIS OCCURRED THREE TIMES IN THE LAST SEVERAL WEEKS BUT WAS UNABLE TO GIVE EXACT DAYS OF OCCURRENCE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866088 ↗
• MalfunctionApr 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE ARE INACCURATE VALUES THAT OCCURRED DURING PATIENT USE WITH A SWAN GANZ TRUE SIZE CATHETER. THE VALUES RECEIVED AND THE VALUES EXPECTED WERE NOT GIVEN BY THE FACILITY. THE CABLES AND MODULES THAT WERE INVOLVED WERE EXCHANGED FOR DIFFERENT EQUIPMENT, BUT THAT DID NOT SOLVE THE ISSUE. INSTEAD, THE EV1000 FLOTRAC WAS EMPLOYED FOR HEMODYNAMIC MONITORING. THE FACILITY REPORTED THAT THIS OCCURRED IN THE LAST SEVERAL WEEKS, BUT WAS UNABLE TO GIVE AN EXACT DATE OF OCCURRENCE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865893 ↗
• MalfunctionNov 14, 2024Failure to Deflate; Failure to Deflate

  AS REPORTED, DURING TESTING THIS SWAN GANZ CATHETER, THE BALLOON DID NOT DEFLATE AT ALL. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20680974 ↗
• MalfunctionAug 18, 2023Difficult or Delayed Positioning; Material Separation; Difficult or Delayed Positioning; Material Separation

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT A KNOT ON A 7F SWAN GANZ CATHETER WAS SEEN WHILE INSIDE THE RIGHT FEMORAL VEIN DURING A RIGHT HEART CATHETER AND STENTING PROCEDURE. IN AN ATTEMPT TO UNTIE THE KNOT, THE CATHETER BROKE INTO TWO PIECES. VASCULAR SURGEON WAS NEEDED TO SURGICAL REMOVE THE DEVICE. THE 7F SWAN GANZ WAS INSERTED VIA A 7F SHEATH IN THE RIGHT FEMORAL VEIN. ALTHOUGH THERE WAS DIFFICULTY OBTAINING THE RIGHT FEMORAL VENOUS ACCESS, A 7F SHEATH WAS ABLE TO BE SUCCESSFULLY INSERTED. STAFF EXPERIENCED DIFFICULTY AGAIN, BUT WITH THE ADVANCING OF THE SWAN GANZ CATHETER. A 0.25 WIRE WAS INSERTED TO HELP ADVANCE THE SWAN. TO HELP TROUBLESHOOT, AN XRAY WAS USED. THE XRAY PANNED DOWN TO THE RIGHT GROIN AREA AND A KNOT IN THE SWAN WAS SEEN. STAFF ATTEMPTED TO UNTIE THE KNOT BY REMOVING THE SHEATH AND SWAN. AS THE SHEATH WAS REMOVED, THE CATHETER BROKE INTO TWO PIECES. A PORTION OF THE SWAN WAS STICKING OUT OF THE SKIN OF THE PATIENT. THE KNOT WAS STILL IN THE RIGHT FEMORAL VEIN. ANOTHER ATTEMPT WAS MADE TO REMOVE THE KNOT. A NEW ACCESS SITE WAS OBTAINED IN THE LEFT FORMAL VEIN AND A SNARE WAS INSERTED VIA A 10F SHEATH. THE SNARE WAS ABLE TO GRAB THE KNOT, BUT THE KNOT WAS UNABLE

  Patient problems: Pain

  MAUDE report 17572664 ↗
• MalfunctionAug 3, 2023

  ELDERLY MALE WITH PAST HISTORY OF CARDIAC DISEASE. PROCEDURE: RIGHT HEART CATH AND STENTING. 7F SWAN-GANZ WAS INSERTED VIA THE 7F SHEATH IN THE RIGHT FEMORAL VEIN. THERE WAS DIFFICULTY ADVANCING THE SWAN. THE X-RAY WAS PANNED DOWN TO THE RIGHT GROIN AREA AND A KNOT IN THE SWAN. THE DECISION WAS MADE TO REMOVE THE SHEATH AND SWAN TOGETHER IN ATTEMPT TO UNTIE THE KNOT. THE SWAN BROKE INTO TWO PIECES AS THE SHEATH WAS REMOVED. VASCULAR SURGEON PERFORMED CUTDOWN AND REMOVED THE KNOTTED SWAN UNDER LOCAL ANESTHETIC. PATIENT DISCHARGED THE NEXT DAY WITHOUT KNOWN HARM. DIFFICULTY OBTAINING RIGHT FEMORAL VENOUS ACCESS. ONCE ACCESS WAS OBTAINED, A 7F SHEATH WAS INSERTED. THE 7F SWAN-GANZ WAS INSERTED VIA THE 7F SHEATH IN THE RIGHT FEMORAL VEIN. THERE WAS DIFFICULTY ADVANCING THE SWAN. AN 0.25 WIRE WAS INSERTED TO HELP ADVANCE THE SWAN. THE SWAN WAS NOT ADVANCING. THE X-RAY WAS PANNED DOWN TO THE RIGHT GROIN AREA AND A KNOT IN THE SWAN WAS SEEN. AN ATTEMPT WAS MADE TO UNTIE THE KNOT. THE DECISION WAS MADE TO REMOVE THE SHEATH AND SWAN TOGETHER IN ATTEMPT TO UNTIE THE KNOT. THE SWAN BROKE INTO TWO PIECES AS THE SHEATH WAS REMOVED. A PORTION OF THE SWAN WAS STICKING OUT OF THE PATIENT'S SKIN. T

  Patient problems: Pain

  MAUDE report 17449980 ↗
• MalfunctionNov 22, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING USE OF A MODEL 131F7P SWAN-GANZ CATHETER, THE PHYSICIAN WAS UNABLE TO GET READINGS FROM THE FIRST SWAN-GANZ, SO SWAPPED IT FOR A SECOND SWAN-GANZ BUT WAS STILL NOT ABLE TO GET READINGS. NO FURTHER ATTEMPTS TO PLACE A SWAN-GANZ WERE MADE. AN ARTERIAL LINE WAS PLACED IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY. PATIENT DEMOGRAPHICS ARE NOT KNOWN. THE EXACT DATE OF THE EVENT IS UNKNOWN. THE DEVICE WAS SAVED FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857506 ↗
• MalfunctionJul 8, 2021Failure to Deflate

  PATIENT WITH HISTORY OF ACUTE RENAL FAILURE ON CHRONIC RENAL FAILURE STAGE IV, SEVERE AORTIC STENOSIS, CONGESTIVE HEART FAILURE, DIABETES MELLITUS AND HYPERTENSION WAS ADMITTED FOR A RIGHT AND LEFT CORONARY ANGIOGRAPHY AND RIGHT HEART CATHETERIZATION. DURING SURGICAL PREPARATION OF THE SWAN-GANZ PULMONARY ARTERY BALLOON CATHETER, THE BALLOON WOULD NOT DEFLATE. THE FAULTY DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12134493 ↗
• MalfunctionOct 27, 2020Difficult to Advance

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND HYPERTENSION, RECENT VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. WHILE HAVING A HEART CATH, THE PERSON INSERTING THE SWAN GANZ HAD PROBLEMS THREADING THE 0.25 WIRE. IT WAS REMOVED FROM THE PATIENT WITHOUT KNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10739844 ↗
• MalfunctionAug 19, 2020Inflation Problem

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION AND SHORTNESS OF BREATH DUE TO AORTIC STENOSIS. WHEN HAVING A HEART CATH, THE BALLOON WOULD NOT INFLATE. PATIENT WENT INTO HEART BLOCK AND A TEMPORARY PACER WAS INSERTED DURING THE PROCEDURE. BALLOON WOULD NOT INFLATE ON AN EDWARDS SWAN CATHETER. THIS CAUSED THE PATIENT TO GO IN TO HEART BLOCK AND TEMPORARY PACER INSERTED. DOCTOR CONSULTED AND THEN HAD A PERMANENT PACEMAKER PLACED A DAY LATER.

  Patient problems: Complete Heart Block

  MAUDE report 10424822 ↗

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-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 determ
• 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 deter
• 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 determi
• 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