Lower risk Medical device recall · FDA · Published February 14, 2023

Edward Lifesciences Swan-Ganz Combo V Catheter Recall: Potential Monitor Error

Edward Lifesciences recalls Swan-Ganz Combo V catheters with possible monitor error messages due to bent distal ends. Affected units have specific model and lot numbers.

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

🇺🇸 FDA recall #Z-1380-2023Medical device Edwards Lifesciences ›

Lower-risk recall

There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Edward Lifesc: Sciences is recalling Swan-Ganz Combo V catheters that may bend beyond their intended shape, causing patient monitors to show errors. This could lead to incorrect readings during medical monitoring. Read more at govinfonow.com/recall/58892-edward-lifesciences-swan-ganz-combo-v-catheter-recall-potential-monitor.

Source Summary by GovInfoNow · govinfonow.com/recall/58892-edward-lifesciences-swan-ganz-combo-v-catheter-recall-potential-monitor · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1380-2023

Cite this page

“Edward Lifesciences Swan-Ganz Combo V Catheter Recall: Potential Monitor Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58892-edward-lifesciences-swan-ganz-combo-v-catheter-recall-potential-monitor. Based on FDA recall #Z-1380-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1380-2023%22&limit=1).

The FDA announced on Feb. 14, 2023, that Edwards Lifesciences LLC is voluntarily recalling its REF 774F75 Swan-Ganz CCOmbo V thermodilution catheters due to a potential bent distal end that may cause monitor errors. The recall affects 326 units distributed across the United States.

How to tell if you have it

Brand: Edwards Lifesciences
Product: Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm
Lot: 64526520
Primary DI Number: 00690103146998
Quantity: 326 units

The hazard

According to the FDA, there is a potential that the distal end of the catheter may be bent beyond its intended curvature. When connected to a patient monitoring device, the monitor may display an error message.

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 Edwards EVOQUE Tricuspid Delivery System Recall (March 27, 2026), Optisite Arterial Cannula Recall (May 14, 2025), and Edwards Lifesciences Acumen IQ Sensor Recall (Oct. 4, 2023). Other recent recalls of similar products include Medline Convenience Kits Recall (May 28, 2026) for Swan-Ganz catheter leak risk.

How to tell if you have this one

Check for the model number REF 774F75 on the catheter's packaging or label. The catheter has an exterior diameter of 7.5F (2.5mm) and a usable length of 110 cm.

Brand
Edwards Lifesciences
Category
Medical device

FDA recall event · 2 products

All 2 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 II
Status
Ongoing
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None

Recall number	Product, codes & lots	Quantity
Z-1379-2023	Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm); Primary DI Number: 00690103146554/ Lot: 64191420 64228620 64229652 64238028 64238630 64243142 64243143 64260684 64260685 64262168 64264946 64278346 64289390 64289391 64289408 64304361 64304362 64304363 64314476 64314477 64314479 64320628 64325327 64328112 64328113 64328114 64328115 64337979 64337980 64337981 64345011 64345012 64355442 64362238 64362239 64362240 64362241 64362242 64373343 64373344 64373345 64381703 64383275 64383276 64383277 64385609 64385610 64385611 64385612 64385613 64398982 64398983 64398984 64410910 64410911 64410912 64410913 64410914 64423626 64423627 64423628 64423629 64423630 64430338 64430339 64430340 64446892 64446893 64446894 64446895 64458777 64458778 64458779 64462548 64462549 64470780 64470781 64470782 64470783 64478098 64478099 64483100 64483101 64483102 64483103 64483104 64496490 64496491 64514042 64540629 64540630 64540631 64552372 64577637 64578749 64578750 64584948 64584949 64584950 64584951 64584952 64603534 64609691 64613340 64617864 64623071 64636398 64664097 64664390 64742870 64746321 64746322 64762706 64769085	59,094 units
Z-1380-2023	Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm); Primary DI Number: 00690103146998/ Lot: 64526520	326 units

Based on the official FDA remedy

What to do — step by step

Check Catheter Model
Look for the model number REF 774F75 on the catheter's packaging or label.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C..

FDA distribution: “US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 14, 2023Firm started the recall
Apr 12, 2023FDA classified it Class II
Apr 19, 2023Published in FDA’s Enforcement Report

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

Is this catheter dangerous?

The recall indicates a potential for monitor errors, but the risk is low as it does not cause immediate injury.

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Link to this recall

<a href="https://govinfonow.com/recall/58892-edward-lifesciences-swan-ganz-combo-v-catheter-recall-potential-monitor">Edward Lifesciences Swan-Ganz Combo V Catheter Recall: Potential Monitor Error (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-1380-2023 (February 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1380-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.