Recall Z-0726-2022 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System
| Date | Jan 27, 2022 |
| Status | Open, Classified |
| Reason | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching. |
| Root cause | Labeling design |
| Action | Starting 27-Jan-2022 and ending 02-FEB-2022, Medtronic initiated an Urgent Medical Device Notice to global customers to inform them of the intent to update the cleaning instructions for power source connector pins on the HVAD" System Monitor AC Adapter, DC Adapter, and Batteries. The communication provided customers the updated instructions, the complaints received as well as the potential hazards of cleaning the power source connector pins. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients. In the Un |
| Quantity | 197,889 units |
| Distribution | Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (So |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.