FDA Device recall Z-1228-2014
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart…
- FDA Device
- Class I
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class I recall of HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart… by Thoratec, citing discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1228-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-03-04 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Thoratec |
| Distribution | US |
Product
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.
Reason
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Identifiers
| code_info | Catalog number 106762 (NAm) 106017 - EU all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1228-2014%22
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