Stra, Azure (xt Sr, Xt Dr, S Sr, S Dr) Mri Surescan, Percepta, Serena, Solara (quad Crt-p, Crt-p) Mri Sure Scan (2019-05-06)
Recall Summary Abbott is recalling certain MRI-compatible pacemakers and cardiac resynchronization therapy devices (Astra, Azure, Percepta, Serena, and Solara models) distributed across Canada because they may malfunction during MRI procedures. The recall affects patients who have received these specific device models. This is classified as a Class I recall, meaning there is a serious risk of adverse health effects.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2019-05-24
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/16f70222-91e1-4d5e-a9c6-0e3c280f1507