Recall Z-1323-2013 ยท DSQ Ventricular (Assist) Bypass
Heartware Inc
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
| Date | May 14, 2013 (initiated Dec 27, 2012) |
| Status | Terminated |
| Reason | HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector. |
| Root cause | Device Design |
| Action | HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their customers on February 7, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. They were asked to sign and return the acknowledgement form to HeartWare. For questions contact your HeartWare representative or Customer Service at 1-877-367-4823. |
| Quantity | 3,544 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switz |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.