Heartware recalls

Heartware appears in 75 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
  FDA Device · Class I · 2020-06-03 · Heartware
  Reason: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
• Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
  FDA Device · Class I · 2020-06-03 · Heartware
  Reason: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
• Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
  FDA Device · Class I · 2020-06-03 · Heartware
  Reason: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
• Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
  FDA Device · Class I · 2020-06-03 · Heartware
  Reason: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
• HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced,…
  FDA Device · Class I · 2020-03-18 · Heartware
  Reason: Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
• HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory…
  FDA Device · Class I · 2020-03-18 · Heartware
  Reason: Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
• Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (H…
  FDA Device · Class II · 2018-12-19 · Heartware
  Reason: HVAD Battery Charger units manufactured with wrong inductors.
• Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is…
  FDA Device · Class II · 2018-10-10 · Heartware
  Reason: 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 the power ports of the control…
• Heartware Medtronic HVAD System for cardiac use
  FDA Device · Class I · 2018-06-06 · Heartware
  Reason: Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching…
• HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect…
  FDA Device · Class I · 2017-05-03 · Heartware
  Reason: In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informi…
• HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation i…
  FDA Device · Class I · 2017-05-03 · Heartware
  Reason: Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
• HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of…
  FDA Device · Class I · 2016-10-26 · Heartware
  Reason: Loose connector ports in controller body.
• HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103
  FDA Device · Class I · 2016-10-19 · Heartware
  Reason: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
• HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only
  FDA Device · Class I · 2016-07-20 · Heartware
  Reason: Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
• HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto…
  FDA Device · Class II · 2015-07-08 · Heartware
  Reason: Complaints with the HVAD Abnormal Power Source Switching.
• HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205
  FDA Device · Class I · 2015-06-24 · Heartware
  Reason: Complaints with the HVAD Internal Controller Alarm Battery failures.
• HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto…
  FDA Device · Class II · 2015-06-17 · Heartware
  Reason: Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
• HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205
  FDA Device · Class I · 2015-06-17 · Heartware
  Reason: Complaints with the HVAD Retraction of Pins within the driveline connector.
• HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205
  FDA Device · Class I · 2015-06-17 · Heartware
  Reason: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
• HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect…
  FDA Device · Class I · 2015-05-20 · Heartware
  Reason: Failures of the splice repair kit if exposed to excessive force.
• HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who ar…
  FDA Device · Class I · 2015-03-04 · Heartware
  Reason: The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
• HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in…
  FDA Device · Class II · 2014-05-21 · Heartware
  Reason: 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.
• Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205
  FDA Device · Class I · 2014-04-30 · Heartware
  Reason: The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
• Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
  FDA Device · Class II · 2013-08-07 · Heartware
  Reason: Potential to electrostatic discharged (ESD)
• Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
  FDA Device · Class II · 2013-05-22 · Heartware
  Reason: HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.