HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
- Company
- Heartware, Inc.
- Recall Initiated
- April 29, 2015
- Posted
- June 11, 2015
- Recall Number
- Z-1726-2015
- Quantity
- 3,747 currently in use
- Firm Location
- Miami Lakes, FL
Reason for Recall
Complaints with the HVAD Retraction of Pins within the driveline connector.
Distribution
Worldwide Distribution -- US, including 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, and VA; and, the 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
Urgent Medical Device Correction letters, dated APR2015, were sent to users. The letters identified the affected device, as well as the reason for the recall and risks involved. Users were asked to review and familiarize themselves with the notice and "Patient Communication." The notice should be forwarded to anyone within customers' organization that need to be aware. Customers are to identify their patients who are currently supported by the HVAD System and distribute the "Patient Communication" to them. A HeartWare representative can assist with that process is needed. Customers should continue to reinforce the messages in the notice with their patients. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of receipt of the notice. Questions or concerns should be directed to a local HeartWare representative. Clinical Support is also available at 1-888-494-6365.