Unify And Unify Assura, Fortify Vr, Dr, St Vr, St Dr, Assura Vr, Assura Dr Quadra Assura, Assura Mp, And Unify Quadra Cardiac Resynchronization Device, Tiered-therapy Cardioverter/defibrillator (201
Recall Summary Several Unify and Assura cardiac resynchronization and defibrillator devices are being recalled due to a potential malfunction that could cause the device to stop delivering therapy to patients. The affected models include various versions of Unify, Assura, and Quadra devices distributed across Canada. This is a Class I recall, the most serious classification, because the devices could fail to provide life-sustaining treatment.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-06-22
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/99aa2cf8-8b75-4c9d-84b7-6ae897fd282a