Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
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.
Read the official notice →- Date
- 2022-05-25
- Country
- United States
- Brand
- Heartware
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
- Classification
- Class II
- Units
- Finland and Turkey
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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