--- title: "Heartware, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Heartware, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/heartware-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Heartware, Inc. recall records **27** reported ongoing 27 records in this archive. Latest source date Oct 31, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Oct 31, 2023 FDA device enforcement ### [HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0475-2024%22) Oct 31, 2023 FDA device enforcement ### [STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0476-2024%22) Oct 31, 2023 FDA device enforcement ### [HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0477-2024%22) Oct 31, 2023 FDA device enforcement ### [PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0478-2024%22) Oct 31, 2023 FDA device enforcement ### [PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0479-2024%22) Oct 31, 2023 FDA device enforcement ### [1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0480-2024%22) Oct 31, 2023 FDA device enforcement ### [PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0481-2024%22) Oct 31, 2023 FDA device enforcement ### [HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0482-2024%22) Oct 31, 2023 FDA device enforcement ### [PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU](https://isitonrecall.com/recall/fda-device-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) instruct... Class II Reported ongoing Distribution: Worldwide [Official source for PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0483-2024%22) May 16, 2023 FDA device enforcement ### [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](https://isitonrecall.com/recall/fda-device-z-1993-2023-heartware-ventricular-assist-device-system-a-monitor-1521us-explore-tech-b-monitor-1521gb-explore-te/) 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 Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK. [Official source for HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Exp...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1993-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare Model 1100](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare Model 1100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0742-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare Model 1101](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare Model 1101](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0743-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare Model 1102](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare Model 1102](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0744-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare HVAD Pump Kit, REF 1103](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare HVAD Pump Kit, REF 1103](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0745-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare HVAD Pump Kit, REF 1104](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare HVAD Pump Kit, REF 1104](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0746-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare HVAD Pump Kit, REF 1104CA-CLIN](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare HVAD Pump Kit, REF 1104CA-CLIN](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0747-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare HVAD Pump Kit, REF 1104JP](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare HVAD Pump Kit, REF 1104JP](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0748-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare HVAD Pump Kit, REF 1205](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare HVAD Pump Kit, REF 1205](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0749-2023%22) Nov 29, 2022 FDA device enforcement ### [HeartWare HVAD Pump Kit, REF MCS1705PU](https://isitonrecall.com/recall/fda-device-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 prolon... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for HeartWare HVAD Pump Kit, REF MCS1705PU](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0750-2023%22) Jun 28, 2022 FDA device enforcement ### [HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE](https://isitonrecall.com/recall/fda-device-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 Reported ongoing Distribution: Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France,... [Official source for HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1512-2022%22) ## Reasons in these listed records - 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... - 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. - 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... - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Heartware, Inc. ### Is there a recall on heartware, inc. right now? This archive contains 27 records, including 27 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Heartware, Inc.](https://isitonrecall.com/check/?q=Heartware%2C%20Inc.) 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