Recall Z-0726-2022— Heartware, Inc.
Class II · Ongoing
Class II FDA medical device recall by Heartware, Inc., initiated 2022-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist Device (HVAD) System. 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..
- Recalling firm
- Heartware, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-27
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist Device (HVAD) System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.