Heartmate 3 Lvas Implant Kit And Heartmate 3 System Controller
HeartMate 3 Recall Summary Abbott is recalling HeartMate 3 LVAS Implant Kits and HeartMate 3 System Controllers across Canada due to labelling and packaging issues that could affect product performance. This is a Class I recall, meaning there is a reasonable probability that use of the product could cause serious injury or death. The devices are used to support heart function in patients with advanced heart failure.
- Product
- HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller
- Reason
- Labelling and packaging - Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2024-07-30
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f6f4f4bb-be30-4d1a-9220-7e3fa152a3f8