Ovation, Ovation Prime, And Ovation IX Abdominal Stent Graft System (2018-08-30)

Recall Summary Ovation, Ovation Prime, and Ovation IX Abdominal Stent Graft Systems are being recalled across Canada due to a medical device issue. These are stent grafts used in abdominal procedures. The recall is classified as Class I, meaning the devices could cause serious harm or death.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-09-07
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/93916013-917f-49dd-b462-7a6eff31d84c