SWAN-GANZ TRUE SIZE 151F7Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103000566), received between Oct 27, 2020 and Jun 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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

• MalfunctionJun 29, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A 151F7 SWAN-GANZ CATHETER FROM LOT 64830010 HAD A BALLOON FAILURE. THE PATIENT CAME TO CCU FROM THE CATH LAB, WHERE THE CATHETER WAS INSERTED. UPON ARRIVAL TO CCU, THE RN ATTEMPTED TO WEDGE THE BALLOON WITH 1.5CC OF AIR TO RECORD A WEDGE PRESSURE. ACCORDING TO THE RN, THE DEVICE WOULD NOT WEDGE AS INDICATED BY NO CHANGE IN WAVEFORM WHILE ATTEMPTING THE WEDGE. THE CATHETER BALLOON WOULD ALSO NOT PASSIVELY DEFLATE WHEN THE SYRINGE PLUNGER WAS RELEASED. THERE WAS NO RESISTANCE ON THE SYRINGE PLUNGER WHEN THE PLUNGER WAS RELEASED. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232003 ↗
• MalfunctionOct 27, 2020Difficult to Advance

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND HYPERTENSION, RECENT VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. WHILE HAVING A HEART CATH, THE PERSON INSERTING THE SWAN GANZ HAD PROBLEMS THREADING THE 0.25 WIRE. IT WAS REMOVED FROM THE PATIENT WITHOUT KNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10739847 ↗

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-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-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