Recall archive / FDA device enforcement
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH — FDA record Z-1106-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 30, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Reason
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Classification
- Class II
- Recalling firm
- Heartware, Inc.
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1106-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Finland and Turkey
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Mar 30, 2022
- Center classification date
- May 17, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.