Overview of recall records associated with Heartware, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 34, Class I: 27.
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of…
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
HVAD Battery Charger units manufactured with wrong inductors.
Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at…
Loose connector ports in controller body.
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Complaints with the HVAD Abnormal Power Source Switching.
Complaints with the HVAD Internal Controller Alarm Battery failures.
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
Complaints with the HVAD Retraction of Pins within the driveline connector.
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
This page summarizes recall records in which the official source identifies Heartware, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
