SWAN-GANZ TRUE SIZE 096F6 (REF 096F6P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690103000245), received between Sep 18, 2023 and Mar 13, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (3 reports).

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

Recalls naming this device

1. Apr 8, 2026Class IIOpen, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE SWAN GANZ THERMODILUTION TRUE SIZE CATHETER. THE SWAN GANZ CATHETER BALLOON WOULD NOT DEFLATE. THERE IS LIMITED INFORMATION THAT WAS PROVIDED. DURING PATIENT USE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595006 ↗
• MalfunctionMar 6, 2025

  A PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB FOR A ROUTINE BIOPSY AND HEMODYNAMIC ASSESSMENT. DURING THE WEDGE PRESSURE ATTEMPT, IT WAS DETERMINED THAT THE WEDGE BALLOON HAD BURST IN THE PULMONARY ARTERY. BALLOON FILLED ACCORDING TO MANUFACTURER INSTRUCTIONS FOR USE. BALLOON MAY HAVE BEEN IN CONTACT WITH STENT IN VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535129 ↗
• MalfunctionMar 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THIS SWAN GANZ CATHETER PROVIDED INACCURATE CARDIAC OUTPUT READINGS. THE PATIENT RECEIVED MEDICATION MANAGEMENT, ADDITIONAL TESTING (ECHOCARDIOGRAM), AND EXTUBATION WAS DELAYED AS A RESULT OF THE INACCURATE VALUES. NO PATIENT INJURY WAS REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520846 ↗
• MalfunctionFeb 11, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED, DURING SET UP, THERE WAS AN ISSUE WITH A SWAN GANZ CATHETER BALLOON. DURING TESTING OF THE BALLOON IT WOULD NOT PROPERLY INFLATE. IT WAS UNDERINFLATED AFTER TESTING AND THEN IT WOULD NOT DEFLATE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356399 ↗
• MalfunctionFeb 11, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED, DURING SET UP, THERE WAS AN ISSUE WITH A SWAN GANZ CATHETER BALLOON. DURING TESTING OF THE BALLOON, IT WOULD NOT PROPERLY INFLATE. IT WAS UNDERINFLATED AFTER TESTING AND THEN IT WOULD NOT DEFLATE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355901 ↗
• MalfunctionNov 6, 2024Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS BLOOD IN THE THERMISTOR CONNECTION. THE RN WAS CALLED TO BEDSIDE TO POSSIBLY ATTEMPT ADDITIONAL TROUBLESHOOTING. PER RN, THE ACCEPTING RN HAD NOTICED THAT THERMISTOR LINE ON PAC HAD BLOOD ON THE END UPON ARRIVAL FROM CVOR & THERMODILUTION WAS VERY VARIABLE IN TERMS OF TEMPERATURE FLUCTUATION, WHICH WAS WITNESSED BY MULTIPLE STAFF. PER THE CLINICIAN THERMODILUTION MEASUREMENTS WERE VARIABLE SINCE ARRIVAL IN CVICU. THE PROBLEM WAS AN UNSTEADY BASELINE TEMPERATURE INTRODUCING NOISE INTO THE SIGNAL FOR TEMPERATURE DEFLECTION WITH COLD SALINE INJECTION. WHEN CHANGING THE THERMISTOR CABLE TO TROUBLESHOOT EARLIER IN THE PM, BLOOD WAS NOTED IN THE THERMISTOR CONNECTOR. THIS WAS INITIALLY THOUGHT TO HAVE RESULTED FROM EXTERNAL CONTAMINATION. HOWEVER, UPON CLOSER INSPECTION IT APPEARED THAT BLOOD-TINGED FLUID MAY HAVE BEEN LEAKING FROM THE SMALL HOLE IN THE THERMISTOR CONNECTOR. CATHETER WAS DISCONTINUED AND RN RETAINED IN A BIOHAZARD BAG. NO ALLEGATION OF PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20623656 ↗
• MalfunctionNov 5, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS BALLOON DEFLATION DIFFICULTY WITH THE SWAN GANZ THERMODILUTION CATHETER. BEFORE THE CATHETER WAS PLACED IN THE PATIENT, THE CLINICIAN TRIED TO INFLATE THEN DEFLATE THE BALLOON. THE BALLOON WOULD NOT DEFLATE. IT IS UNCLEAR WHETHER THE BALLOON SYRINGE WAS REMOVED FROM THE GATE VALVE. THE DEVICE WAS DISCARDED AT THE HOSPITAL, IT IS NOT AVAILABLE FOR RETURN AND PRODUCT EVALUATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614768 ↗
• MalfunctionSep 24, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT WHEN TESTING A SWAN BEFORE INSERTING INTO THE PATIENT THE BALLOON WOULD NOT DEFLATE. THE DOCTOR AND REP BOTH ATTACHED/REATTACHED THE SYRINGE TO THE BALLOON, TRIED TO DEFLATE IT, BUT IT STAYED INFLATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291947 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SWAN GANZ BALLOON DISLODGED FROM THE CATHETER DURING A PROCEDURE IN THE CATH LAB. THE PATIENT WAS ADMITTED AND BEING CATHETERIZED FOR FURTHER DIAGNOSIS AND TREATMENT OF CHRONIC SYSTOLIC HEART FAILURE. UPON FIRST PASS INTO THE HEART, THE BALLOON WAS INFLATED AND WEDGED. THE BALLOON WAS VISIBLE UNDER FLUOROSCOPY. THE CATHETER WAS THEN REMOVED AND REINSERTED FOR A SECOND PASS. UPON ATTEMPTING TO INFLATE AND WEDGE, NO BALLOON WAS VISIBLE UNDER FLUOROSCOPY AFTER SECOND INSERTION. THE CATHETER WAS REMOVED AND THERE WAS NO VISIBLE BALLOON. PER HOSPITAL REPORT, THERE WERE NO VISIBLE EVIDENCE OF FOREIGN MATERIAL IN PATIENT VASCULATURE AT ANY POINT DURING THE PROCEDURE, WHICH LEAD THE STAFF TO BELIEVE THE PIECE OF BALLOON WAS CAUGHT IN THE SHEATH. THE PATIENT DID NOT HAVE ANY ADVERSE EVENT OR INJURY RELATED TO THE PROCEDURE AND REMAINED HOSPITALIZED FOR FURTHER CARE AS THE PATIENT REQUIRED A PACEMAKER. THE SALES REP WAS ABLE TO OBSERVE THE SWAN AND IT APPEARED AS IF THE BALLOON WAS COMPLETELY SHEARED OFF. THERE WERE NO FRAGMENTS REMAINING ON THE CATHETER. INFORMATION OF THE INTRODUCER BRAND OR SIZE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770256 ↗