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U.S. Department of Health and Human Services

Class 2 Device Recall QuickDraw Venous Cannula

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  Class 2 Device Recall QuickDraw Venous Cannula see related information
Date Initiated by Firm November 27, 2019
Create Date January 10, 2020
Recall Status1 Completed
Recall Number Z-0800-2020
Recall Event ID 84381
510(K)Number K981995  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Code Information All lots
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact
949-250-6827
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = HEARTPORT, INC.
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