Acurate Neo2 And Acurate Prime

Recall Summary Boston Scientific is recalling ACURATE neo2 and ACURATE Prime heart valves across Canada due to performance concerns. These are implantable aortic heart valves that may not function as intended. The recall affects all patients who received these devices.

Product
ACURATE neo2 and ACURATE Prime
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-12-02
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e8fa8582-9ec6-4dfe-902c-73c0a0256337