Recall Z-0006-2017 ยท DSQ Ventricular (Assist) Bypass
HeartWare, Inc
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
| Date | Aug 17, 2016 |
| Status | Open, Classified |
| Reason | Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. |
| Root cause | Component design/selection |
| Action | HeartWare notified their customers with an Urgent Medical Device Recall notice on 8/17/2016 of the HVAD Pump, listing the US Product: Model No. 1103 and the International Product: Model No.: 1104. The letter discussed the reason for the recall as well as the risk to health. Customers were to identify affected product in their inventory; and, complete and return the acknowledgement form. Acknowledgement should be provided no later than 30 days from date of the letter either to the HeartWare representative; or, via e-mail to FSCA @Heartware.com; or, FAX the signed form to (305) 364-2665. Af |
| Quantity | 344 pumps |
| Distribution | Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Leba |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.