Corevalve Evolut R & Corevalve Evolut Pro (2020-10-23)
CoreValve Evolut R & CoreValve Evolut Pro Recall CoreValve Evolut R and CoreValve Evolut Pro heart valves are being recalled across Canada due to a defect that may cause the valve to move out of position after implantation. The recall affects all CoreValve Evolut R and CoreValve Evolut Pro devices distributed in Canada. This is a Class I recall, meaning there is a serious risk to patient health.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2020-11-13
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/becd20d7-9963-4bde-bbd2-746159c6f833