HeartWare Ventricular Assist System — Class I medical device recall Z-1604-2015
Ongoing recall by HeartWare Inc, reported 2015-05-20, distributed nationwide. Failures of the splice repair kit if exposed to excessive force.
| Recall number | Z-1604-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartWare Inc, Miami Lakes, FL, United States |
| Recall initiated | 2015-04-29 |
| Classified | 2015-05-14 |
| Reported by FDA | 2015-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, GB, IT, NL, TR |
| Quantity | 35 |
| Lot numbers | 480786, 483769, 490692, 532770, 539664, 567949, 598189, 654090, 672401, 678800, 690423, 833963, 873159, 880816 |
| Model numbers | ASY00116, ASY00281 |
Product
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Reason for recall
Failures of the splice repair kit if exposed to excessive force.
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-1604-2015. 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.