Product Description
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.
Reason for Recall
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Action Details
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. Affected product should be returned upon receipt of replacement product; and, the completion form should also be completed and returned. Questions or concerns should be directed to a local HeartWare representative.
Distribution Pattern
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, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
Code Information / Serial Numbers
All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.