Recall Z-1512-2022 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
| Date | Aug 18, 2022 (initiated Jun 28, 2022) |
| Status | Open, Classified |
| Reason | Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging. |
| Root cause | Device Design |
| Action | Medtronic (Heartware) issued a Medical Device Correction notice on 06/28/2022 by letter. The notice, addressed to the VAD Coordinators, explained the issues and provided the following recommendations: 1. Please remind your patients to always keep two sources of power connected to their controller and have fully charged spare batteries available at all times. 2. Remind patients to acknowledge and report alarms. 3. Follow the Instructions for Use (IFU) for proper power source management. 4. Inform patients to be vigilant if the battery indicator lights do not decrease over time while the batter |
| Quantity | 19616 batteries |
| Distribution | Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirat |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.