SWAN-GANZ TRUE SIZE 111F7Recalls & reported problems
Edwards Lifesciences LLC · TRUE SIZE CATHETER DOUBLE LUMEN · Class 2
All models of SWAN-GANZ TRUE SIZE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103000276), received between Aug 23, 2024 and Aug 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other CATHETER, OXIMETER, FIBEROPTIC devices
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- HemoSphere HEMSGM10Edwards Lifesciences LLC · Catheter, Oximeter, Fiberoptic1 recall5 reports
- SWAN GANZ SGPT64PEdwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic1 recall0 reports
- SWAN-GANZ SGPT755PEdwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic1 recall0 reports
- FLOTRAC MHD85Edwards Lifesciences LLC · CATHETER, OXIMETER, FIBEROPTIC1 recall0 reports
- SWAN GANZ SGPT54Edwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic1 recall0 reports
- HemoSphere Alta ALTAALL1Edwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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