Use caution Medical device recall · FDA · Published November 27, 2019

Edwards QuickDraw Venous Cannula Recall: Risk of Blood Loss After 6 Hours of Use

Edwards Lifesciences recalls QuickDraw Venous Cannula models QD22 and QD25 due to risk of blood loss if used longer than 6 hours, especially during ECMO. Affected units have specific UDI numbers.

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

🇺🇸 FDA recall #Z-0800-2020Medical device Edwards Lifesciences ›

Use caution until it’s fixed

If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling two types of QuickDraw Venous Cannula (QD22 and QD25) because using them for more than 6 hours, particularly during ECMO treatment, can cause the cannula to detach from its connector and lead to significant blood loss. Read more at govinfonow.com/recall/66426-edwards-quickdraw-venous-cannula-recall-risk-of-blood-loss-after.

Source Summary by GovInfoNow · govinfonow.com/recall/66426-edwards-quickdraw-venous-cannula-recall-risk-of-blood-loss-after · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0800-2020

Cite this page

“Edwards QuickDraw Venous Cannula Recall: Risk of Blood Loss After 6 Hours of Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66426-edwards-quickdraw-venous-cannula-recall-risk-of-blood-loss-after. Based on FDA recall #Z-0800-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0800-2020%22&limit=1).

The FDA announced on 2019-11-27 that Edwards Lifesciences, LLC voluntarily recalled QuickDraw Venous Cannulas due to a risk of separation from the connector during use. This defect can cause significant blood loss if the device is used longer than six hours.

How to tell if you have it

Brand: Edwards Lifesciences
Product: QuickDraw Venous Cannula
REF: QD22, UDI: 00690103182699
REF: QD25, UDI: 00690103182705
All lots

The hazard

If the venous cannula is used in an unintended manner, such as for longer than six hours or during extracorporeal membrane oxygenation (ECMO), it may separate from its connector. This separation can result in significant blood loss.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since 2017-07-06. Recent brand recalls include the 2026-03-27 Edwards EVOQUE Tricuspid Delivery System Recall and the 2025-05-14 Edwards FEM-FLEX II Femoral Arterial Cannula Recall. Other recent recalls of similar products include Medtronic EOPA Arterial Cannula Recall (2026-06-24) and Medtronic Pediatric Cannula Recall (2026-05-25).

How to tell if you have this one

Check for the product model numbers QD22 or QD25 on the cannula packaging or label. The unique device identifier (UDI) numbers 00690103182699 and 00690103182705 are also associated with these recalled items.

Brand
Edwards Lifesciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your cannula has model numbers QD22 or QD25 and UDI numbers 00690103182699 or 00690103182705.

Where it went and when

Where it was distributed

Distributed in 41 states, and outside the U.S.

FDA distribution: “U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. O.U.S. (Foreign): Brazil, Colombia, Albania, Australia, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

Nov 27, 2019Firm started the recall
Jan 10, 2020FDA classified it Class II
Jan 22, 2020Published in FDA’s Enforcement Report
May 28, 2024FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/66426-edwards-quickdraw-venous-cannula-recall-risk-of-blood-loss-after">Edwards QuickDraw Venous Cannula Recall: Risk of Blood Loss After 6 Hours of Use (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-0800-2020 (November 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0800-2020 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.