HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB ...
FDA Device Recall #Z-1993-2023 — Class II — May 16, 2023
Recall Summary
| Recall Number | Z-1993-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 16, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Heartware, Inc. |
| Location | Miami Lakes, FL |
| Product Type | Devices |
| Quantity | 19 units |
Product Description
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
Lot / Code Information
a) Model Number 1521US, GTIN 00888707009256, Serial/Lot Numbers: MON500010, MON500012, MON500016, MON500028, MON500026, MON500005, MON500006, MON500007. b) Model Number 1521GB, GTIN 00888707006521, Serial/Lot Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061. c) Model Number 1521IL, GTIN 00888707010108, Serial/Lot Number: MON400017. d) Model Number 1521DE, GTIN 00888707010085, Serial/Lot Numbers: MON400045, MON400021, MON400013.
Other Recalls from Heartware, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0478-2024 | Class II | PUMP 1103 HVAD (HeartWare Ventricular Assist De... | Oct 31, 2023 |
| Z-0482-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STER... | Oct 31, 2023 |
| Z-0481-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist De... | Oct 31, 2023 |
| Z-0479-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist De... | Oct 31, 2023 |
| Z-0475-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STER... | Oct 31, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.