—#178198

Product

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

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K981995
Affected lot / code info: All lots

Why it was 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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-11-27
Terminated: 2024-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.