SWAN-GANZ VIP+ 834F75Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00690103151756), received between Dec 12, 2024 and Sep 18, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 reports).

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

4 other recalls cover devices cleared under the same FDA submission (K160084); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER HAD INACCURATE READINGS. THE CATHETER WAS REMOVED THE NEXT DAY. NO ALLEGATION OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801273 ↗
• MalfunctionDec 12, 2024Failure to Deflate; Failure to Deflate

  AS REPORTED, ONCE THIS SWAN-GANZ CATHETER WAS INSERTED INTO PATIENT, IT COULD NOT BE DEFLATED. BEFORE INSERTION, THE CATHETER WAS FLUSHED AND THE BALLOON TESTED SUCCESSFULLY. THE BALLOON INFLATED EASILY AND DEFLATED PASSIVELY. UPON INSERTION TO PATIENT, THE BALLOON INFLATED SMOOTHLY. BEFORE FLOATING, THE PA (PULMONARY ARTERY) PRESSURE WAS REGISTERING A HIGH READING ALREADY. THE CATHETER WAS FLOATED BUT THE USER THOUGHT IT WAS COILING IN THE RIGHT ATRIUM, SO IT WAS DECIDED TO REMOVE THE CATHETER. HOWEVER, THE BALLOON DID NOT DEFLATE PASSIVELY. THE BALLOON WAS TRIED TO BE DEFLATED MANUALLY AS PER CONSULTANT ANESTHETIST'S INSTRUCTIONS. THE TOE PROBE (TRANS-OESOPHAGEAL ECHOCARDIOGRAM) WAS UTILIZED TO MAKE SURE THE BALLOON WAS NOT INFLATED BEFORE WITHDRAWING, BUT IT WAS FINALLY REMOVED WITH THE BALLOON INFLATED WITHOUT ANY ISSUES. ONCE REMOVED, THE BALLOON APPEARED TO BE INFLATED AND HALF-FILLED WITH A CLEAR FLUID OF UNKNOWN ORIGIN. THE PROBLEM WAS SOLVED USING A NEW SWAN-GANZ CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912113 ↗

Recalls under the same FDA submission

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

• 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
• 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-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