Heartware HVAD Pump Implant Kit — Class II medical device recall Z-1323-2013
Terminated recall by Heartware Inc, reported 2013-05-22, distributed nationwide. HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HV
| Recall number | Z-1323-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware Inc, Miami Lakes, FL, United States |
| Recall initiated | 2012-12-27 |
| Classified | 2013-05-14 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2013-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, FR, GB, GR, IL, IN, IT, JP, LB, LT, MY, NL, NO, NZ, PL, SA, SG, TR, ZA |
| Quantity | 3,544 |
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason for recall
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
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-1323-2013. 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.