Recall Z-1726-2015 ยท DSQ Ventricular (Assist) Bypass
HeartWare Inc
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.
| Date | Jun 11, 2015 (initiated Apr 29, 2015) |
| Status | Open, Classified |
| Reason | Complaints with the HVAD Retraction of Pins within the driveline connector. |
| Root cause | Device Design |
| Action | 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 shoul |
| Quantity | 3,747 currently in use |
| 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, Denm |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.