Heartware Ventricular Assist System - Hvad Implant Kit (2020-12-08)
HeartWare Ventricular Assist System Recall Summary HeartWare is recalling HVAD Implant Kits distributed across Canada due to a medical device issue. This recall affects patients who have received or may receive this implantable heart pump device. The FDA classified this as a Class I recall, indicating a serious potential health concern.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2020-12-24
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6a88384d-6a0b-4950-882d-41812597fa10