HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
- Company
- Heartware, Inc.
- Recall Initiated
- April 29, 2015
- Posted
- June 8, 2015
- Recall Number
- Z-1698-2015
- Quantity
- 3,747 currently implanted worldwide
- Firm Location
- Miami Lakes, FL
Reason for Recall
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Distribution
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
Lot / Code Info
Serial #: ALL HeartWare HVAD systems currently in use.
Root Cause
Device Design
Action Taken
HeartWare sent an Urgent Medical Device Correction letter to customers on May 25, 2015. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Review the enclosed notice and Patient Communication. 2. Forward the notice to those individuals within their organization who need to be aware of its contents. 3. Identify the patients currently supported by the HVAD System. 4. Distribute the "Patient Communication" to their patients directly via FedEx or some other reliable means of communication. 5. Continue to reinforce the messages set forth in the notice with their patients during their regularly scheduled appointments. 6. Complete, sign and return the Acknowledgement and Completion Form to HeartWare within 30 days of receipt of this letter. For questions contact your local HeartWare representative or the 24-Hour Clinical Support personnel at 1-888-494-6365.