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Use caution Medical device recall · FDA · Published October 22, 2019

Edwards EZ Glide Aortic Cannula Recall: Risk of Separation During Surgery

Edwards Lifesciences recalls specific EZ Glide aortic cannula models due to potential separation during cardiopulmonary bypass, risking significant blood loss. Affected units have unique identifiers and lot numbers.

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

🇺🇸 FDA recall #Z-0420-2020Medical deviceEdwards Lifesciences ›
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Contact the company

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

Edwards Lifesciences is recalling certain EZ Glide aortic cannulas that may separate from their connectors during heart surgery, potentially causing serious blood loss. Patients using these devices should contact the manufacturer for details on affected units and next steps. Read more at govinfonow.com/recall/66618-edwards-ez-glide-aortic-cannula-recall-risk-of-separation-during.

Source Summary by GovInfoNow · govinfonow.com/recall/66618-edwards-ez-glide-aortic-cannula-recall-risk-of-separation-during · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0420-2020

Cite this page

“Edwards EZ Glide Aortic Cannula Recall: Risk of Separation During Surgery.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66618-edwards-ez-glide-aortic-cannula-recall-risk-of-separation-during. Based on FDA recall #Z-0420-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0420-2020%22&limit=1).

The FDA announced on 2019-10-22 that Edwards Lifesciences, LLC is recalling EZ Glide Aortic Cannulas due to the possibility of separation from their connector. This defect could cause a breach of circuit during cardiopulmonary bypass, potentially resulting in significant blood loss.

How to tell if you have it

  • Brand: Edwards Lifesciences
  • Product: EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector
  • REF #: EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A, EZS24TA
  • Lot #: 203876, 207654, 217024, 226788, 205724, 207655, 217025, 226938, 205775, 208823, 217048, 227494, 205868, 208893, 218185, 227886, 205920, 208894, 218457, 228009, 205921, 209901, 218539, 228259, 205922, 209904, 219090, 228549, 206369, 210110, 219212, 228558, 206372, 210111, 219561, 229051, 206373, 212032, 220146, 229054, 206374, 212033, 220151, 229827, 206768, 212034, 220157, 230690, 206769, 212035, 220802, 230894, 206770, 212258, 220803, 231105, 206771, 212280, 222841, 231109, 206772, 212959, 222913, 231111, 206773, 213506, 222914, 231291, 206774, 213914, 222915, 231485, 206775, 214214, 223174, 232109, 206776, 214216, 224233, 232437, 206777, 214716, 224235, 234138, 206778, 214717, 224662, 207319, 214961, 224707, 207320, 215239, 225306, 207321, 215495, 225884, 207322, 216123, 225885, 207323, 216196, 226188, 207324, 216627, 226596, 207636, 216628, 226597, 207638, 216632, 226691
  • Quantity: 62,431 units

The hazard

The cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since 2017-07-06. Other recent recalls include the Edwards EVOQUE Tricuspid Delivery System Recall (2026-03-27), the Edwards FEM-FLEX II Femoral Arterial Cannula Recall (2025-05-14), and the Edwards Lifesciences TruWave Vamp Pressure Monitoring Set Recall (2023-10-04). Other recent recalls of similar products include Medtronic EOPA Arterial Cannula Recalls (2026-06-24) and the Medtronic Perfusion Systems EOPA Cannula Recall (2026-06-24).

How to tell if you have this one

Check for the product's unique identifier (UDI) codes listed in the recall notice, such as EZC21A (00690103174182) or EZS24A (00690103172119). Also look for the specific lot numbers provided in the recall record.

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

What to do — step by step

  1. Check Product Details

    Review the unique identifier (UDI) codes and lot numbers listed in the recall notice to determine if your device is affected.

  2. Contact Manufacturer

    Reach out to Edwards Lifesciences directly for guidance on next steps if your device is confirmed affected.

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: named in the noticeVTNew 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: nationwideSDIowa: 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 noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas,…” 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Oct 22, 201912. FDA classified it Class II: Nov 18, 201923. Published in FDA’s Enforcement Report: Nov 27, 201934. FDA terminated the recall: Jun 29, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  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.

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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-0420-2020 (October 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0420-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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