Recall Z-1102-2022— Heartware, Inc.
Class II · Ongoing
Class II FDA medical device recall by Heartware, Inc., initiated 2022-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104. Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system..
- Recalling firm
- Heartware, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-30
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Reason for recall
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.