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Use caution Medical device recall · FDA · Published March 21, 2019

Edwards Lifesciences EV1000A Monitor Fire Risk Due to Liquid Ingress

Edwards Lifesciences recalls EV1000A, EV1000NI, and EV1000CS monitors for potential fire risk from liquid entering AC power outlets. Affected units may need replacement.

🇺🇸 FDA recall #Z-1193-2019Medical deviceEdwards Lifesciences ›
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Contact the company

Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688
✎ GovInfoNow plain-language explainer

What happened, in plain English

Edwards Lifesciences is recalling three models of EV1000 Clinical Platform monitors because liquid can enter the AC power outlets, causing a short circuit and possible fire. This could lead to serious injury or property damage if the device is used without proper precautions. Read more at govinfonow.com/recall/68574-edwards-lifesciences-ev1000a-monitor-fire-risk-due-to-liquid-ingress.

Source Summary by GovInfoNow · govinfonow.com/recall/68574-edwards-lifesciences-ev1000a-monitor-fire-risk-due-to-liquid-ingress · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1193-2019

Cite this page

“Edwards Lifesciences EV1000A Monitor Fire Risk Due to Liquid Ingress.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68574-edwards-lifesciences-ev1000a-monitor-fire-risk-due-to-liquid-ingress. Based on FDA recall #Z-1193-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1193-2019%22&limit=1).

Why it’s dangerous

Liquid can enter the AC power outlets of the monitor, causing an electrical short circuit. This short circuit may lead to a fire hazard, especially if the device is used in environments where moisture is present.

Who’s affected

Healthcare professionals using the EV1000A monitor for fluid management are most at risk. Patients receiving care with these monitors may also be affected.

How to tell if you have this one

Check for the model numbers EV1000A, EV1000NI, or EV1000CS on the monitor. These devices were sold for clinical use to optimize fluid management.

  • Brand
    Edwards Lifesciences
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Liquid Ingress

    Inspect the AC power outlets for signs of liquid damage or corrosion.

  2. Contact Manufacturer

    Reach out to Edwards Lifesciences for guidance on next steps if liquid ingress is found.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution - US Nationwide : FL, MD, NY, TX, VA, CO, OK, MO, CA, DE, TN, NC, DC, PA, MA, OR, SC, OH, WI, KS, NV, MI, IL, KY, GA, NJ, WA, CT, IN, MN, WV, LA, MS, AL, SD, NE, IA, AZ, ID, HI, UT, ME,MT, NM, AK, NH, RI, AR, ND, WY,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 4.7 years after the firm started it.

1. Firm started the recall: Mar 21, 201912. FDA classified it Class I: May 21, 201923. Published in FDA’s Enforcement Report: May 29, 201934. FDA terminated the recall: Nov 28, 2023420192023
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Is this recall affecting my home use?

No, this recall applies only to clinical use in healthcare settings.

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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-1193-2019 (March 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1193-2019 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA