HeartMate II System Controller Product Usage: HeartMate II is a… — Class I medical device recall Z-1228-2014
Terminated recall by Thoratec Corporation, reported 2014-04-02, distributed nationwide. Discovery of serious injuries and deaths associated with the process of changing from a primary System control
| Recall number | Z-1228-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corporation, Pleasanton, CA, United States |
| Recall initiated | 2014-03-04 |
| Classified | 2014-03-21 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2015-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, FR, GB, IE, IL, IT, LB, LT, NL, PL, SA, SE, SG, SI, TR |
| Quantity | 4,120 |
| Model numbers | 106762 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1228-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.