Lower risk Medical device recall · FDA · Published December 21, 2018

Edwards Lifesciences Swan Ganz Catheters with Incorrect Lumen Assembly Recalled

Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters (REF 131F7P) with incorrect lumen assembly that may cause reversed pressure readings. Affected units include specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0763-2019Medical device Edwards Lifesciences ›

Lower-risk recall

These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.

Take action

Contact the company

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling Swan Ganz Thermodilution Catheters (REF 131F7P) because they have incorrect lumen assembly. This can cause clinicians to see reversed pressure values and waveforms, which might lead to inaccurate hemodynamic readings during medical procedures. Read more at govinfonow.com/recall/69212-edwards-lifesciences-swan-ganz-catheters-with-incorrect-lumen-assembly-recalled.

Source Summary by GovInfoNow · govinfonow.com/recall/69212-edwards-lifesciences-swan-ganz-catheters-with-incorrect-lumen-assembly-recalled · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0763-2019

Cite this page

“Edwards Lifesciences Swan Ganz Catheters with Incorrect Lumen Assembly Recalled.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69212-edwards-lifesciences-swan-ganz-catheters-with-incorrect-lumen-assembly-recalled. Based on FDA recall #Z-0763-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0763-2019%22&limit=1).

Edwards Lifesciences, LLC recalled Edwards Lifesciences Swan Ganz Thermodilution Catheter units worldwide on Dec. 21, 2018, according to the FDA. The device has incorrect lumen assembly causing reversed pressure readings.

How to tell if you have it

Brand: Edwards Lifesciences
Product: Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7)
Lot Numbers: 61321241, 61176369, 61176374, 61311580, 61176373, 61321254
Units affected: 875

The hazard

The Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since July 6, 2017. Other recent recalls of similar products include Becton Dickinson Swan-Ganz Catheter Recall (April 8, 2026) and Medline Convenience Kits Recall (May 28, 2026).

How to tell if you have this one

Check for the model number REF 131F7P in the product packaging. Affected units include specific lot numbers: 61321241, 61176369, 61176374, 61311580, 61176373, 61321254.

Brand
Edwards Lifesciences
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
Worldwide Distribution

Recall number	Product, codes & lots	Quantity
Z-0762-2019	Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.; Lot Numbers: 61321177, 61227528	277 units
Z-0763-2019	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 to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.; Lot Numbers: 61321241, 61176369, 61176374, 61311580, 61176373, 61321254	875 units
Z-0764-2019	Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.; Lot Number: 61176314	9 units
Z-0765-2019	Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.; Lot Numbers: 61176367, 61176370	459 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Identify the lot number on the catheter packaging to determine if it is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.9 years after the firm started it.

Dec 21, 2018Firm started the recall
Jan 31, 2019FDA classified it Class I
Feb 6, 2019Published in FDA’s Enforcement Report
Nov 2, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the specific model number of the recalled catheters?

The recalled model is REF 131F7P (5 pack of 131F7).

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Link to this recall

<a href="https://govinfonow.com/recall/69212-edwards-lifesciences-swan-ganz-catheters-with-incorrect-lumen-assembly-recalled">Edwards Lifesciences Swan Ganz Catheters with Incorrect Lumen Assembly Recalled (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0763-2019 (December 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0763-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.