Z-0800-2020Class II

QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705

Name: Z-0800-2020 QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Creator: Edwards Lifesciences, LLC
Published: 2019-11-27
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2019-11-27 / Terminated

FDA source

Edwards Lifesciences, LLC began a recall of QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705 on 2019-11-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0800-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-27
Posted: 2020-01-10
Terminated: 2024-05-28
Recalling firm: Edwards Lifesciences LLC
Product: QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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.
FDA root cause: Other
Action: On 11/27/19, Urgent Medical Device Safety Notices were mailed to customers (Attention: Risk Management Departments). Customers were informed the following: 1. Review the field safety notice to understand the potential hazard. 2. Meet and review with the appropriate clinical staff at your hospital. 3. Complete and return the acknowledgment form attached to this letter via fax (949-250-2525). 4. Distribute this notice within your organization or to any organization where the devices under the safety alert have been transferred. 5. Make the information available to personnel that may be using these devices as part of continuing communication and training. 6. Instructions for Use are being modified to add a contraindication for long term use (greater-than 6 hours, particularly during extracorporeal membrane oxygenation (ECMO) procedures. 7. Product return is not required. If you have additional questions, please contact customer service at 800-424-3278, Option 1, from 5:00 AM - 4:30 PM PST.
Quantity in commerce: 27168
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, 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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0800-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0800-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10

Product code DWF

K981995Class IIQuickdraw Venous CannulaHeartport, Inc. / cleared 1999-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)