Expansure Transseptal Dilation System (2019-05-12)

ExpanSure Transseptal Dilation System Recall The ExpanSure Transseptal Dilation System, a medical device used in cardiac procedures, has been recalled across Canada. The device was classified as a Class I recall, which indicates a serious safety issue. This recall affects all units of this product that were distributed throughout Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-05-22
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/f7ae3ec9-a6fb-46d1-9245-e64e39cc9e1d