SWAN-GANZ TRUE SIZE TS105F5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103018295), received between Jul 7, 2022 and Jun 7, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 7, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THIS EDWARDS 5FR SWAN-GANZ WAS DEFECTIVE. THE THERMISTOR CONNECTOR DID NOT WORK. THE EVENT OCCURRED WHEN TRYING TO CALCULATE OUTPUTS. THE CUSTOMER TRIED SWITCHING OUT EVERY CABLE AND ULTIMATELY TRIED A SECOND CATHETER. THERE WAS NO INJURY TO THE PATIENT. MEDWATCH 3902560000-2022-8054 WAS RECEIVED WITH ADDITIONAL INFORMATION THAT CHANGED THE REPORTABILITY. IT WAS REPORTED THAT THE SWAN WAS PREPPED AND CHECKED, AND EVERYTHING MECHANICALLY WORKED PROPERLY. ONCE INSERTED, THE PHYSICIAN ATTEMPTED TO OBTAIN THERMODILUTIONS. THE NUMBERS WERE VERY INACCURATE AND VERY EXTREME IN BOTH DIRECTIONS WITH NO INDICATION AS TO WHY. PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951208 ↗

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-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