SWAN-GANZ VIP 831F75 (REF 831F75P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00690103218282), received between Mar 4, 2025 and Sep 23, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K160084, K231248); 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 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 6 most recent of 6 reports, 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 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER HAD SALINE AND MEDICATION LEAK AT THE CVP PORT, WHERE THE WHITE FACTORY INSTALLED CAP JOINS THE BLUE TUBING. LOT NUMBER MAY BE 66225267 AS THIS WAS THE REMAINING LOT ON THE SHELF. THERE WERE NO PATIENT INJURIES. THIS EVENT OCCURRED IN THE PAST SO SPECIFIC INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857180 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER HAD SALINE AND MEDICATION LEAK AT THE CVP PORT, WHERE THE WHITE CAP JOINS THE BLUE TUBING. LEAKAGE OCCURRED 5 DAYS AFTER USE. CATHETER WAS REMOVED AS THE STAFF WAS UNABLE TO USE THE PORT. LOT NUMBER MAY BE 66225267 AS THIS WAS THE REMAINING LOT ON THE SHELF. THERE WERE NO PATIENT INJURIES, BUT PATIENT MAY HAVE HAD A NEW SWAN INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857166 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER HAD SALINE AND MEDICATION LEAK AT THE CVP PORT, WHERE THE WHITE FACTORY INSTALLED CAP JOINS THE BLUE TUBING. LEAKAGE OCCURRED 3 DAYS AFTER USE. CATHETER WAS REMOVED AS THE STAFF WAS UNABLE TO USE THE PORT. LOT NUMBER MAY BE 66225267 AS THIS WAS THE REMAINING LOT ON THE SHELF. THERE WERE NO PATIENT INJURIES, BUT PATIENT MAY HAVE HAD A NEW SWAN INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857113 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON OPENING AND INSPECTION OF THIS SWAN-GANZ CATHETER, MATERIAL PROTRUDING FROM THE CATHETER WAS FOUND CLOSE TO THE DISTAL TIP. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER EVALUATION RESULTS, APPROXIMATELY 4MM IN LENGTH OF THE CATHETER BODY APPEARED TO BE MISSING AT 2CM FROM THE DISTAL TIP. PATIENT DEMOGRAPHIC DATA UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890438 ↗
• 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 21520796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160084, K231248. One submission often covers many models, so check the product and lot details in each record.

• Z-2203-2026 · Apr 8, 2026 · Open, Classified
  Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
• 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 det
• 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
• 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 de
• 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 dete