Every recall we track for Heartware, Inc. — 58 in all — plus the complaints and injury reports the public filed about them.
Heartware recalls specific HVAD pump models (1104CA-CLIN) for updated instructions on controller fault alarms and component lifespans. No immediate action needed beyond reviewing new guides.
Heartware recalls HVAD Sterile Implant Kit Model 1102 (serial numbers HW1000-HW999) for updated instructions clarifying controller fault alarms and component lifespan.
Heartware recalls specific HVAD pump models (US) for updated instructions on controller fault alarms and component lifespans to ensure safe use.
Heartware recalls specific models of ventricular assist device implant kits for updated safety instructions on controller faults and component lifespans. No immediate action needed but updates clarify risks.
Heartware recalls PUMP 1104 HVAD implant kits with serial numbers HW10001-HW23653. Updates to instructions clarify controller fault alarms and component lifespan. No immediate action needed but users should review updated manuals.
Heartware recalls specific HVAD Sterile Implant Kit Model 1100 units with serial numbers 001-181. Updates clarify when Controller Fault alarms occur and component lifespans to ensure safe device operation.
Heartware recalls PUMP 1104 HVAD implant kits with updated instructions for Controller Fault alarms and component lifespans to ensure safe use.
Heartware recalls specific HVAD implant kits (model 1205) for updated instructions on controller fault alarms and component lifespans. Affected units require revised manuals to ensure safe device operation.
Heartware recalls PUMP 1103 HVAD implant kits with serial numbers starting from HW10991 to HW27250. Updates to instructions clarify when Controller Fault alarms occur and how to troubleshoot, plus information about component lifespan.
Heartware recalls specific models of ventricular assist device monitors due to logfiles from updated units not being compatible with Autologs web portal. Affected units include 1521US, 1521GB, 1521IL, and 1521DE Explore Tech monitors with listed serial numbers.
Heartware recalls HVAD Pump Kit REF 1104JP with serial numbers HW40657-HW41848. Hardened driveline cover may delay critical connections, risking patient harm during emergencies.
Heartware recalls HVAD Pump Kit REF 1205 with serial numbers listed. Hardened driveline cover may cause delays in accessing the pump connector, risking patient harm during emergencies.
Heartware Model 1102 devices with specific serial numbers may have hardened driveline covers that delay access to the pump connector, risking patient harm during emergencies. Contact Medtronic for assessment.
Heartware recalls HVAD Pump Kit REF MCS1705PU due to hardened driveline cover causing delayed access to pump connections, potentially leading to patient harm. Affected units have specific serial numbers.
Heartware recalls HVAD Pump Kit REF 1104 with serial numbers HW25347 to HW35999 due to hardened driveline cover that may delay access to the pump connector, risking patient harm during emergencies. Contact Medtronic for assessment.
Heartware recalls HVAD Pump Kit REF 1103 due to hardened driveline cover that may delay access to the pump connector, risking patient harm during emergencies. Affected units have specific serial numbers listed in the recall.
Heartware recalls Model 1101 pacemakers with hardened driveline covers that could delay critical connections, risking patient harm during emergencies. Affected units have specific serial numbers.
Heartware recalls HVAD Pump Kit REF 1104CA-CLIN due to hardened driveline cover causing delayed access to pump connections, potentially leading to patient harm during emergencies.
Heartware recalls Model 1100 pacemakers with serial numbers HW001 to HW181 due to hardened driveline covers that may delay critical access, risking patient harm during emergencies.
Heartware recalls HVAD System Batteries (Product Number 1650DE) due to battery performance issues that may cause failure to power the controller or accept charge. Affected units have specific serial numbers and GTIN.
Heartware recalls HVAD System Model 1104 due to Finnish and Turkish translation errors in controller displays and instructions, which could lead to miscommunication with patients and responders.
Heartware recalls HVAD ventricular assist device system pamphlets with Finnish and Turkish translation errors in instructions and patient guides. Affected units include specific lot numbers and language versions.
Heartware recalls HVAD System Controller Model 1420-Controller 2.0 due to Finnish and Turkish translation errors in displays and documentation. Affected units have specific serial numbers and GTINs.
Heartware recalls HVAD System Controller Model 1420 due to Finnish and Turkish translation errors in displays and manuals, potentially causing confusion for patients and responders.
Heartware recalls HVAD System Model 1521DE due to Finnish and Turkish translation errors in controller displays and instructions, which could cause misunderstandings in critical medical situations.
Heartware recalls HVAD System Controller Model 1407DE Kit due to Finnish and Turkish translation errors in displays and documentation. Affected units have specific serial numbers and GTINs.
Heartware recalls specific HVAD system models for updated cleaning instructions to avoid removing lubricant from power connector pins, which could cause power switching issues.
Heartware recalls Medtronic HVAD Pump Implant Kits (product numbers 1100-1104JP, 1205, MCS1705PU) due to potential driveline repair complications during controller exchanges.
Heartware recalls HVAD Implant Kit REF MCS1705PU due to higher neurological adverse events and mortality risks compared to other ventricular assist devices.
Heartware recalls HVAD Driveline Extension Cable REF 100US due to higher neurological adverse events and mortality risks compared to other LVADs. All units are affected.
Heartware recalls HVAD Implant Kit REF 110: higher neurological adverse events and mortality risks compared to other LVADs. Stop using if you have this device.
Heartware recalls HVAD Pump Implant Kit REF 1104 due to higher neurological adverse events and mortality risks compared to other ventricular assist devices. All units with specific serial numbers are affected.
Heartware recalls HVAD Pump Implant Kit REF 1103 due to higher neurological adverse events and mortality risks compared to other ventricular assist devices.
Heartware recalls HVAD Driveline Extension Cable REF 100 due to higher neurological adverse events and mortality risks compared to other ventricular assist devices.
Heartware recalls HVAD Pump Accessories REF MCS175: Neurological adverse events and mortality risks identified in clinical studies. Affected units include specific serial numbers and GTINs.
Heartware recalls HVAD Outflow Graft REF MCS172: Higher neurological adverse events and mortality risk compared to other ventricular assist devices. Affected units include specific serial numbers and GTINs.
Heartware recalls HVAD Pump Implant Kit REF 1153 due to higher neurological adverse events and mortality compared to other LVADs. Affected units include all serial numbers sold with GTIN 0088870:000147.
Heartware recalls HVAD Pump Implant Kit REF 1125 due to higher neurological adverse events and mortality risks compared to other LVADs, with internal pump failure concerns.
Heartware recalls HVAD Pump Implant Kit REF MCS170: Impeller shroud height may not meet safety limits. Affected patients should contact Heartware for guidance.
Heartware recalls updated instructions for use and patient manuals for HVAD System components to address carrying case orientation, driveline cover safety, and power-up sequence clarity. These updates prevent potential misuse of the critical heart failure support device.
Heartware recalls Medtronic HVAD Packaged Monitors (models 1500-1522) due to potential cable damage from misalignment when connecting to controller ports.
Heartware recalls Medtronic HVAD Alarm Adapter (Product 1450) due to potential cable damage to controller ports from misalignment. Affected units may cause device malfunction.
Heartware recalls specific HVAD Controller adapters (product numbers 1425AU-1430US) due to potential port damage from cable misalignment. Affected users should contact Heartware for details.
Heartware recalls Medtronic HVAD Monitor Data Cable (Product 1575) due to potential port damage from cable misalignment. Affected units may cause controller port damage when connecting cables.
Heartware recalls Medtronic HVAD Battery models 1650, 1650CA-CLIN, 1650DE due to potential cable damage to controller ports from misalignment. Affected users should contact Heartware for details.
Heartware recalls Medtronic HVAD Controller models 1400-1407 with potential port damage from cable misalignment. Affected users should contact Heartware for details.
Heartware recalls updated instructions for HeartWare HVAD system to address alarms that resolve quickly, which may indicate intermittent issues needing clinician evaluation.
Heartware recalls updated instructions for HVAD system to clarify controller connection verification using a beep instead of audible click. This correction helps users identify proper device connection without confusion.
Heartware recalls Medtronic HVAD Pump Implant Kits with specific model numbers and serial ranges due to pumps failing to start or restart properly. Affected units include models 1100-1205 and specific serial numbers. No immediate action is required for safe use but may need monitoring.
Heartware recalls HVAD Pump Implant accessories (REF 1153) due to potential tears in the Outflow Graft and Strain Relief screw breaking during pre-implant assembly. All units distributed are affected.
Heartware recalls HVAD Pump Implant Kit (REF 1104JP) due to potential tears in the Outflow Graft and Strain Relief screw breaking during pre-implant assembly. Affected units have specific serial numbers and GTINs.
Heartware recalls HVAD Pump Implant Kit (REF 1104) due to risk of outflow graft tears and strain relief screw breakage during pre-implant assembly. Affected units have specific serial numbers and GTINs listed in the recall notice.
Heartware recalls HVAD Pump Outflow Graft (REF 112:1125) due to potential tears and Strain Relief screw breakage during assembly. Affected units include all lots and serial numbers in distribution.
Heartware recalls HVAD Pump Implant Kit (REF 1103) due to risk of outflow graft tears and strain relief screw breakage during pre-implant assembly. Affected units have specific serial numbers and GTINs listed. Consumers should check their device details and contact Heartware for guidance.
Heartware recalls HVAD System Battery Charger AC Adapters with model numbers 1640 (all serials) due to risk of inserting into HVAD Controller power port. Affected units include specific model numbers and serials listed in the recall notice.
Heartware recalls HVAD System Battery Charger models with potential for incorrect AC adapter insertion into HVAD Controller power port. Affected units include specific model numbers and serials listed in the recall notice.
Heartware recalls HVAD Battery Charger Model 1600US units with wrong inductors. These chargers may not charge batteries properly, risking system failure. Affected units have specific model numbers listed in the recall.
Heartware recalls HVAD System Controllers (models 1403, 1407, 1420) due to potential hairline cracks at power ports from water/fluid exposure. Affected units have serial numbers CON300175 to CON320540.
