SWAN-GANZ 131F7 (REF 131F7P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103000412), received between Nov 29, 2024 and Jan 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (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 16, 2026.

Recalls naming this device

1. Apr 8, 2026Open, 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.

• MalfunctionJan 8, 2026Material Fragmentation

  AS REPORTED DURING USE THE SWAN GANZ CATHETER WAS TESTED BEFORE A CASE AND THE BALLOON INFLATED. IT INFLATED IN THE BODY AS WELL BUT ONCE IT WAS REMOVED THE BALLOON HAD ALREADY DEFLATED WITHOUT THE DOCTOR DOING SO., THEY TRIED TO INFLATE THE BALLOON AGAIN OUTSIDE THE BODY AND IT WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24015691 ↗
• MalfunctionNov 29, 2024Appropriate Device Problem Term/Code Not Available; Failure to Deflate; Appropriate Device Problem Term/Code Not Available; Failure to Deflate

  AS REPORTED, DURING DEVICE PREPARATION, THE BALLOON OF THIS SWAN-GANZ CATHETER DID NOT DEFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810716 ↗

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 determi
• 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 determ
• 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 deter
• 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