SWAN-GANZ CONTROLCATH TRUE SIZE C144F7Recalls & reported problems
Edwards Lifesciences LLC · SWAN-GANZ POLYMER BLEND TRUE SIZE C-TIP CONTROLCATH TD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103005134), received between Apr 18, 2025 and Apr 18, 2025 — classified as 1 malfunction.
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.
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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2025Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT, DURING DEVICE PREP, THE BALLOON OF A SWAN GANZ CATHETER COULD NOT DEFLATE. THERE WERE NO PATIENT INJURIES REPORTED. FURTHER INFORMATION IS NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21865822 ↗
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-0762-2019 · Dec 21, 2018 · TerminatedEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly det
- Z-0765-2019 · Dec 21, 2018 · TerminatedEdwards 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 · TerminatedEdwards 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 · TerminatedEdwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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