HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Reported: May 25, 2022 Initiated: March 30, 2022 #Z-1102-2022
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.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 236 units
- Distribution
- Finland and Turkey
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104. Recalled by Heartware, Inc.. Units affected: 236 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1102-2022.
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