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, Inc. is recalling 2,225 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.
Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.
Heartware, Inc. is recalling HVAD Pump Implant accessories due to potential tears in the outflow graft and breakage of the strain relief screw during assembly.
Heartware, Inc. is recalling 2,614 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.
Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers because users may mistakenly insert the AC adapter into the HVAD Controller power port.
Heartware, Inc. is recalling 5,489 HVAD System Battery Charger AC Adapters because users might mistakenly insert them into the HVAD Controller power port.
Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.
Heartware, Inc. is recalling HVAD System Controllers because they may develop hairline cracks at the power ports, potentially failing to meet standards for protection against water or fluid ingress.
Heartware, Inc. is recalling Ventricular Assist System Controllers due to loose connector ports. The recall affects 4,235 units worldwide, including 7,272 in the U.S.
HeartWare is recalling 344 HVAD pumps worldwide because foreign material in the driveline connector could cause electrical faults.
Heartware, Inc. is recalling 18,631 HeartWare Ventricular Assist System batteries due to premature depletion. The recall covers devices distributed nationwide in the US.
HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.
HeartWare Inc. is recalling HVAD systems due to internal controller alarm battery failures. The recall affects 3,747 currently implanted devices worldwide.
HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.
HeartWare Inc is recalling HVAD systems due to complaints of damaged or bent connection pins in the power supply ports of the VAD controller.
HeartWare Inc is recalling HVAD systems due to complaints of discolored and cracked driveline outer sheaths. The recall affects 3,747 units currently in use.
HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.
HeartWare Inc is recalling 4,845 HeartWare Controllers used in ventricular assist systems because they are more susceptible to electrostatic discharge (ESD) than newer models.
HeartWare Inc is recalling HVAD Pump Implant Kit batteries that may not provide two hours of support or behave unusually.
HeartWare Inc is recalling HVAD Pump Implant Kits because the driveline connector housing may separate. This defect could affect patients using the device for heart failure.
HeartWare Inc is recalling HVAD Pump Implant Kits due to a potential electrostatic discharge (ESD) hazard. The recall covers 76 units in the US and 82 internationally.
Heartware Inc. is recalling 3,544 HVAD Pump Implant Kits worldwide because the driveline connector may loosen.