SWAN-GANZ VIPRecalls & reported problems across all models
Edwards Lifesciences LLC · 4 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 VIP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 4 models of SWAN-GANZ VIP by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2022 and Sep 23, 2026 — classified as 4 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (18 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 VIP 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 4 of these models · Recall details · FDA record ↗
Most reported SWAN-GANZ VIP problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings18
- Fluid/Blood Leak6
- Appropriate Device Problem Term/Code Not Available4
- Detachment of Device or Device Component4
- Incorrect Measurement4
- Failure to Deflate2
- Material Rupture2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Hypersensitivity/Allergic reaction4
- Hemorrhage/Blood Loss/Bleeding2
- Ectopic Heartbeat1
SWAN-GANZ VIP models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SWAN-GANZ VIP 831F75CATHETER, FLOW DIRECTED1 recall23 reports
- SWAN-GANZ VIP+ 834F75CATHETER, FLOW DIRECTED1 recall12 reports
- SWAN-GANZ VIP 831F75CATHETER, FLOW DIRECTED1 recall6 reports
- SWAN-GANZ VIP 782F75MCatheter, continuous flush1 recall4 reports
Recent SWAN-GANZ VIP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872949 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820324 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that during use of the Swan-Ganz catheter it gave inaccurate values. Displayed values and expected values are unknown. There were microcracks in the blue lumen at the connection with the proximal injectate lumen. There was no allegation of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820322 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that during use of the Swan-Ganz catheter it gave inaccurate values. Displayed values and expected values are unknown. There were microcracks in the blue lumen at the connection with the proximal injectate lumen. There was no allegation of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820318 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that during use of the Swan-Ganz catheter it gave inaccurate values. Displayed values and expected values are unknown. There were microcracks in the blue lumen at the connection with the proximal injectate lumen. There was no allegation of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820304 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820288 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that during use of the Swan-Ganz catheter it gave inaccurate values. Displayed values and expected values are unknown. There were microcracks in the blue lumen at the connection with the proximal injectate lumen. There was no allegation of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820282 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that during use of the Swan-Ganz catheter it gave inaccurate values. Displayed values and expected values are unknown. There were microcracks in the blue lumen at the connection with the proximal injectate lumen. There was no allegation of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820271 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that during use of the Swan Ganz catheter, it provided high CVP values. The catheter was placed in the OR shortly before the inaccurate values were seen in the unit. After re-zeroing and troubleshooting the CVP transducer, the CVP line was moved to the double lumen Central Venous Catheter (CVC) and the reading there was an expected value. There were microcracks in the blue lumen at the connection with the proximal injectate lumen. The RN was still able to check thermodilution utilizing the blue PA line but monitored CVP on double lumen CVC instead. There was no allegation of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820264 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820263 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50743210 ↗MalfunctionMar 2, 2026
CALIBRATING THE SWAN MACHINE IN PREP FOR THE CASE IN CT KEPT ERRORING. CHANGED OUT OXIMETRY CABLE, AND REBOOTED SWAN MACHINE WITH NO CHANGE. SWITCHED OUT THE KIT AND THE ERROR CODE ENDED RULING THE KIT BEING FAULTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480977 ↗MalfunctionNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING PLACEMENT OF THE SWAN-GANZ CATHETER, WHEN TRYING TO FLOAT IT, THE CATHETER WOULD GET CAUGHT AROUND THE PATIENT'S AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD). TO REPLACE THE CATHETER THE PATIENT REQUIRED AN EMERGENT TRIP TO THE CATH LAB. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619256 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER, THERE WAS A PINHOLE SIZED LEAK BELOW ONE OF THE PORTS. THE CATHETER WAS EXCHANGED FOR A NEW ONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416458 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER, THERE WAS A PINHOLE SIZED LEAK BELOW ONE OF THE PORTS. THE CATHETER WAS EXCHANGED FOR A NEW ONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416433 ↗
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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