Heartware Recalls
75 recalls on record · May 22, 2013 to December 13, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 3, 2017Medical DevicesFDA
Heartware recalls HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-card
Hazard: Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
October 26, 2016Medical DevicesFDA
Heartware, Inc. recalls HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in pat
Hazard: Loose connector ports in controller body.
October 19, 2016Medical DevicesFDA
HeartWare, Inc recalls HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX.
Hazard: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
July 20, 2016Medical DevicesFDA
Heartware, Inc. recalls HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-
Hazard: Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
July 8, 2015Medical DevicesFDA
HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of
Hazard: Complaints with the HVAD Abnormal Power Source Switching.
June 24, 2015Medical DevicesFDA
HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205.
Hazard: Complaints with the HVAD Internal Controller Alarm Battery failures.
June 17, 2015Medical DevicesFDA
HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of
Hazard: Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
June 17, 2015Medical DevicesFDA
HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intende
Hazard: Complaints with the HVAD Retraction of Pins within the driveline connector.
June 17, 2015Medical DevicesFDA
HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205.
Hazard: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
May 20, 2015Medical DevicesFDA
HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the drivel
Hazard: Failures of the splice repair kit if exposed to excessive force.
March 4, 2015Medical DevicesFDA
HeartWare Inc recalls HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplanta
Hazard: The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
May 21, 2014Medical DevicesFDA
HeartWare Inc recalls HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-card
Hazard: Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
April 30, 2014Medical DevicesFDA
HeartWare Inc recalls Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, a
Hazard: The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
August 7, 2013Medical DevicesFDA
HeartWare Inc recalls Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Hazard: Potential to electrostatic discharged (ESD)
May 22, 2013Medical DevicesFDA
Heartware Inc recalls Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Hazard: HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.