Date: May 5, 2017
The following new items were added to the CDRH web pages on May 4, 2017. Previous CDRH New Items can be found on the CDRHNew Page.
- Medtronic Recalls HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device Because it May Cause Electrical Issues or Pump Stops
- Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) Expands Recall for Ventricular Assist Device Controllers and DC Adapter
- Emergency Use Authorization - Zika MAC-ELISA (CDC) Updated