HeartWare, Inc.
Miami Lakes, FL, US
HeartWare, Inc. appears in FDA device records in Miami Lakes, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 75 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for HeartWare, Inc. in 1997.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007042319 | 3007042319 | HeartWare, Inc. | 14400 NW 60th Ave, Miami Lakes, FL 33014 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 75| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0483-2024 | PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0482-2024 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0481-2024 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0480-2024 | 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0479-2024 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0478-2024 | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0477-2024 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0476-2024 | STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-0475-2024 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components | Class II | Open, Classified | |
| Z-1993-2023 | 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 | 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. | Class II | Open, Classified | |
| Z-0750-2023 | HeartWare HVAD Pump Kit, REF MCS1705PU | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0749-2023 | HeartWare HVAD Pump Kit, REF 1205 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0748-2023 | HeartWare HVAD Pump Kit, REF 1104JP | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0747-2023 | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0746-2023 | HeartWare HVAD Pump Kit, REF 1104 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0745-2023 | HeartWare HVAD Pump Kit, REF 1103 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0744-2023 | HeartWare Model 1102 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0743-2023 | HeartWare Model 1101 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-0742-2023 | HeartWare Model 1100 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. | Class II | Open, Classified | |
| Z-1512-2022 | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE | Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging. | Class I | Open, Classified | |
| Z-1107-2022 | HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Instructions For Use (FI) HVAD System Instructions For Use (FI) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Instructions For Use - FI HVAD System Instructions For Use (FI) HVAD System OUS Patient Manual (FI-Finnish) HVAD System Emergency Responder Guide (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System OUS Instructions For Use (TR-Turkish) | 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. | Class II | Open, Classified | |
| Z-1106-2022 | HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH | 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. | Class II | Open, Classified | |
| Z-1105-2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0 | 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. | Class II | Open, Classified | |
| Z-1104-2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 | 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. | Class II | Open, Classified | |
| Z-1103-2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit | 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. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain