Manufacturer
72 recalls in our database name Heartware, Inc. as the manufacturing or recalling firm.
Of the 72 recalls from Heartware, Inc. we have scored against our rubric, 13 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (15%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.
Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.
Heartware recalls HVAD ventricular assist pump instructions to clarify controller fault alarm conditions and component useful life expectations.
HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.
HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.
Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life instructions.
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.
Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.
Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.
HeartWare HVAD Pump Kit driveline covers may harden over time, making it difficult or impossible to access the driveline connector for urgent servicing. Delayed access could result in patient harm from prolonged pump stoppage.
HeartWare HVAD Pump Kit driveline covers may harden over time, making them difficult to remove for urgent servicing. In an emergency scenario requiring driveline access, delays could harm patients.
The driveline cover on some HeartWare Model 1101 implanted pumps may harden over time, making it difficult to access the driveline connector. This could delay urgent maintenance, potentially causing patient harm.
A hardened driveline cover on the HeartWare HVAD Pump Kit may prevent or delay access to the driveline to controller connector. If urgent servicing is needed, the delay could result in patient harm from pump malfunction.
HeartWare Model 1102 cardiac assist devices are being recalled because the driveline cover may harden over time, preventing timely access to the critical driveline connector during urgent clinical situations.
HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.
The driveline cover on HeartWare HVAD Pump Kits may harden over time, preventing access to the driveline to controller connector. This could delay urgent intervention for critical device issues.
Driveline cover hardening in HeartWare HVAD Pump Kits may prevent access to critical connectors, potentially delaying emergency repairs. Affected patients should contact their Medtronic field representative for assessment.
HeartWare HVAD ventricular assist pump kits may develop hardened driveline covers that impair access to critical connectors. If urgent servicing is needed, delayed access could result in patient harm from prolonged pump stoppage.
HeartWare HVAD System Batteries are being recalled due to electrical faults that may prevent the battery from powering the device controller, accepting charges, or maintaining charge. Approximately 19,616 batteries distributed worldwide are affected.
HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.
HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.
Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.
The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.
HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.