CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report
QuickDraw Venous Cannula recalled by Edwards Lifesciences
Edwards Lifesciences is recalling QuickDraw Venous Cannula, distributed in 41 states. The recall was initiated on 27 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0800-2020
- FDA event ID
- 84381
- Recalling firm
- Edwards Lifesciences, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2019
- FDA classified
- 10 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 Nov 2019 | Recall initiated by company | |
| 10 Jan 2020 | Classified by FDA | +44 days |
| 22 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Where it was distributed
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, Belgium, Brazil, Canada, Canary Islands, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Namibia, Poland, Romania, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Is QuickDraw Venous Cannula recalled?
Yes. Edwards Lifesciences recalled QuickDraw Venous Cannula on 27 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0800-2020.
Why was it recalled?
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.
Which lots are affected?
All lots
Where was it sold?
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, Belgium, Brazil, Canada, Canary Islands, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Namibia, Poland, Romania, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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