SWAN-GANZ TRUE SIZERecalls & reported problems across all models
Edwards Lifesciences LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SWAN-GANZ TRUE SIZE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 8 models of SWAN-GANZ TRUE SIZE by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2020 and Jun 26, 2025 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (8 reports).
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
SWAN-GANZ TRUE SIZE 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.
- 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 5 of these models · Recall details · FDA record ↗
Most reported SWAN-GANZ TRUE SIZE problems
Device problems
- Material Puncture/Hole8
- Deflation Problem5
- Burst Container or Vessel3
- Failure to Deflate3
- Incorrect, Inadequate or Imprecise Result or Readings3
- Detachment of Device or Device Component1
- Difficult to Advance1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Embolism/Embolus1
- Hemorrhage/Blood Loss/Bleeding1
SWAN-GANZ TRUE SIZE models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SWAN-GANZ TRUE SIZE 096F6CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall9 reports
- SWAN-GANZ TRUE SIZE 151F7CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- SWAN-GANZ TRUE SIZE TS105F5CATHETER, FLOW DIRECTED1 recall2 reports
- SWAN-GANZ TRUE SIZE 132F5CATHETER, FLOW DIRECTED1 recall0 reports
- SWAN-GANZ TRUE SIZE 096F6CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- SWAN-GANZ TRUE SIZE 123F6CATHETER, FLOW DIRECTED11 reports
- SWAN-GANZ TRUE SIZE 111F7CATHETER, OXIMETER, FIBEROPTIC1 report
- SWAN-GANZ TRUE SIZE 114F7CATHETER, FLOW DIRECTED1 report
Recent SWAN-GANZ TRUE SIZE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, BEFORE USE IN PATIENT, THE BALLOON OF THIS SWAN-GANZ CATHETER LEAKED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS RUPTURED NEAR TO DISTAL BONDING SITE, THE EDGES OF BALLOON LATEX DID NOT APPEAR TO MATCH UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22334441 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionAug 23, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, AFTER INSERTING THIS SWAN-GANZ CATHETER, WHILE INFLATING, THE DOCTOR FELT A DROP OF AIR AND THE BALLOON WAS TORN. THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY. THE BALLOON HAD BEEN INFLATED WITH THE DEDICATED SYRINGE THAT COMES IN THE KIT AND PRIOR TO INSERTION, THE DOCTOR HAD TESTED THE BALLOON IN A TUB OF WATER AND THE BALLOON WAS NORMAL. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED NEXT TO DISTAL END. THE BALLOON EDGES APPEARED NOT TO MATCH UP AT THE RUPTURED REGION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20045655 ↗MalfunctionJun 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF A TS105F5 IT WAS UNABLE TO ACHIEVE A STABLE TEMP. THE DEVICE WAS BEING USED DURING A CARDIAC CATH. THE CASE WAS COMPLETED WITH A NEW CATHETER. THERE WAS NO PATIENT INJURY. DEVICE IS AVAILABLE FOR RETURN. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484935 ↗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 ↗MalfunctionJun 29, 2023Deflation Problem; Deflation Problem
IT WAS REPORTED THAT A 151F7 SWAN-GANZ CATHETER FROM LOT 64830010 HAD A BALLOON FAILURE. THE PATIENT CAME TO CCU FROM THE CATH LAB, WHERE THE CATHETER WAS INSERTED. UPON ARRIVAL TO CCU, THE RN ATTEMPTED TO WEDGE THE BALLOON WITH 1.5CC OF AIR TO RECORD A WEDGE PRESSURE. ACCORDING TO THE RN, THE DEVICE WOULD NOT WEDGE AS INDICATED BY NO CHANGE IN WAVEFORM WHILE ATTEMPTING THE WEDGE. THE CATHETER BALLOON WOULD ALSO NOT PASSIVELY DEFLATE WHEN THE SYRINGE PLUNGER WAS RELEASED. THERE WAS NO RESISTANCE ON THE SYRINGE PLUNGER WHEN THE PLUNGER WAS RELEASED. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17232003 ↗
Other Edwards Lifesciences LLC products
- Edwards SAPIEN 315 models · 6,905 reports · 1 recall
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
- INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
- EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
- SAPIEN 3 Ultra RESILIA4 models · 881 reports
- SAPIEN 3 Ultra System3 models · 876 reports
- FOGARTY32 models · 486 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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