Recall Z-0058-2011 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percuta
| Date | Oct 13, 2010 (initiated Sep 1, 2010) |
| Status | Terminated |
| Reason | Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection |
| Root cause | Device Design |
| Action | Thoratec Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 30, 2010, to all customers. The letter described the affected product, description and symptoms of problem, and immediate action to be taken by the customers. The customers were instructed to: 1) contact all ongoing patients using the affected Systems Controllers (serial numbers starting with "EPC") to determine if they are experiencing any unexplained intermittent alarms or have any bent pins in the connectors between the System Controller and the power sources, if so, have them return to the hospital so that |
| Quantity | 8965 units |
| Distribution | Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX , UT, VA, WA, and WI; and countries including: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.