Recall Z-1698-2015 ยท DSQ Ventricular (Assist) Bypass
HeartWare Inc
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.
| Date | Jun 8, 2015 (initiated Apr 29, 2015) |
| Status | Open, Classified |
| Reason | HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 3,747 currently implanted worldwide |
| 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, Egy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.