HeartWare Ventricular Assist Device System — Class II medical device recall Z-1993-2023
Ongoing recall by Heartware, Inc., reported 2023-06-28, distributed nationwide. Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Nu
| Recall number | Z-1993-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2023-05-16 |
| Classified | 2023-06-22 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | BH, GB |
| Quantity | 19 units |
| UPC / GTIN / UDI-DI | 00888707006521, 00888707009256, 00888707010085, 00888707010108 |
| Lot numbers | MON400013, MON400017, MON400021, MON400039, MON400045, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061, MON500005, MON500006, MON500007, MON500010, MON500012, MON500016, MON500026, MON500028 |
| Model numbers | 1521DE, 1521GB, 1521IL, 1521US |
Product
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Reason for recall
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
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-1993-2023. 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.