SWAN-GANZ HI-SHORE TRUE SIZE 141F7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103000504), received between Jan 30, 2024 and Dec 27, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT THIS SWAN GANZ CATHETER, THE PULMONARY ARTERY PRESSURE FLUCTUATED GREATLY, EVEN REACHING NEGATIVE VALUES. THE DEVICE WAS REPLACED WITH A NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025004 ↗
• MalfunctionJan 30, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON OF A 141F7 SWAN GANZ CATHETER WAS NOT ABLE TO DEFLATE. EVENT OCCURRED DURING DEVICE PREP. THERE WAS NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611090 ↗
• MalfunctionJan 30, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON OF A 141F7 SWAN GANZ CATHETER WAS NOT ABLE TO DEFLATE. EVENT OCCURRED DURING DEVICE PREP. THERE WAS NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611089 ↗

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-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-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