HVAD Pump Implant KitRecalls & reported problems across all models

We found 5 models of HVAD Pump Implant Kit by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 5,895 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2017 and Sep 29, 2026 — classified as 1,127 deaths, 3,763 injuries, 1,005 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (2,006 reports).

11 FDA recall records name at least one of these models by its device identifier, 11 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HVAD Pump Implant Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 31, 2023Open, Classified

   Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

   Z-0483-2024 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

2. Oct 31, 2023Open, Classified

   Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

   Z-0478-2024 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

3. Nov 29, 2022Open, Classified

   Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

   Z-0745-2023 · Root cause: Device Design · Recall details · FDA record ↗

4. Apr 14, 2022Open, Classified

   The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.

   Z-1207-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

5. Mar 30, 2022Open, Classified

   Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.

   Z-1110-2022 · Root cause: Labeling design · names 3 of these models · Recall details · FDA record ↗

6. Jun 3, 2021Open, Classified

   Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

   Z-2195-2021 · Root cause: Unknown/Undetermined by firm · names 2 of these models · Recall details · FDA record ↗

7. Jun 3, 2021Open, Classified

   Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

   Z-2188-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

8. Feb 26, 2021Open, Classified

   IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

   Z-1438-2021 · Root cause: Device Design · Recall details · FDA record ↗

9. Feb 26, 2021Open, Classified

   IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

   Z-1469-2021 · Root cause: Device Design · Recall details · FDA record ↗

10. Nov 19, 2020Open, Classified

    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 restart attempts at a rate substantially higher than pump in the overall population.

    Z-0946-2021 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

11. Apr 3, 2020Open, Classified

    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.

    Z-2055-2020 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported HVAD Pump Implant Kit problems

HVAD Pump Implant Kit models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HVAD Pump Implant Kit 1103

  Ventricular (Assist) Bypass
  6 recalls424 deaths2,952 reports
• HVAD® Pump Implant Kit 1103

  Ventricular (Assisst) Bypass
  4 recalls666 deaths2,737 reports
• HVAD® Pump Implant Kit MCS1705PU

  Ventricular (Assist) Bypass
  7 recalls36 deaths203 reports
• HVAD® Pump Implant Kit MCS1705PU

  Ventricular (Assist) Bypass
  4 recalls1 report
• HVAD Pump Implant Kit 1103

  Ventricular (Assisst) Bypass
  1 death2 reports

Recent HVAD Pump Implant Kit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital unresponsive and was intubated. A CT scan of the brain/head demonstrated a large hemorrhagic stroke. The event was reported as neurological dysfunction/stroke. The patient was receiving Coumadin (warfarin) and aspirin (ASA) and was reported to be compliant with anticoagulation therapy. Anticoagulation was reported to be therapeutic at the time of the event. Due to the severity of the hemorrhagic stroke, the patient remained unresponsive and required mechanical ventilation. The patient's family discussed withdrawal of life-sustaining treatment, including discontinuation of HVAD support. It is unknown whether the reported hemorrhagic stroke was related to the HVAD system. No causal relationship between the device and the reported event has been established. It was subsequently reported that the patient was transitioned to hospice care. The HVAD pump was turned off/disconnected, and life-sustaining treatment was withdrawn. The patient subsequently expired. The VAD will not be returned.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 50934544 ↗
• MalfunctionSep 28, 2026Pumping Problem

  It was reported that the Ventricular Assist Device (VAD) patient exhibited a high-watt alarm while operating at the higher end of the expected power range for the programmed speed. The logfiles demonstrated a circadian rhythm that appeared to have nothing adverse showing. The patient¿s urine remains normal in color, with lactate dehydrogenase (LDH) 245 and International Normalized Ratio (INR) 2.4. They are planning to increase his high watt alarm to 9.0w, they did a speed increase to 9/8 and think it's average power runs high normally because he is a very active young patient. The VAD remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922876 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem; Pumping Problem; Noise, Audible

  It was reported that the patient had a suspected inflow/intra-pump thrombus and elevated plasma free hemoglobin with persistent low trough on waveform. The patient had an echocardiogram transthoracic (TTE) which showed LV 5.5 with aortic valve opening. Labs were performed, lactate dehydrogenase (LDH) was unreadable due to hemolysis and plasma free hemoglobin was 120. The patient was initiated on tissue plasminogen activator (TPA) treatment. It was also noted that a grinding noise was heard upon auscultating pump. The VAD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Hemolysis; Thrombosis/Thrombus

  MAUDE report 50922744 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem; Pumping Problem

  It was reported that the Ventricular Assist Device (VAD) patient exhibited a motor start event with parameters outside the typical o perating range, during which a High Watt alarm was logged. The patient also experienced a controller fault alarm while at home. The patient independently exchanged the controller at home without reported difficulty or incident. The VAD remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920084 ↗
• MalfunctionSep 25, 2026Power Problem; Pumping Problem

  Review of log file data revealed a motor start event with parameters outside of the typical range. It was also reported that the controller exhibited a power up event indicating a loss of power to the controller. the VAD and Controller remain in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900703 ↗
• InjurySep 23, 2026Pumping Problem

  It was reported that a Ventricular Assist Device (VAD) patient experienced frequent low-flow alarms, fatigue, and an Upper Gastroint estinal Bleed (GIB). The patient underwent upper Esophagogastroduodenoscopy (EGD) to identify the location of the bleed. During the procedure a polypectomy was performed. The patient received a Packed red blood cells (PRBC) infusion.  The VAD remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Fatigue; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50867493 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50808011 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50621016 ↗
• MalfunctionAug 26, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461265 ↗
• InjuryJul 30, 2026Disconnection; Pumping Stopped; Power Problem

  It was reported that a Ventricular Assist Device (VAD) patient was admitted to the hospital for altered mental status with concern for infection possibly due to a urinary tract infection (UTI).  Review of logfiles noted suction alarms, a VAD stop due to a driveline disconnect and multiple controller loss of power events.  There was concern that the altered mental status was playing a role in these events.  The VAD and Controller remain in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Altered State of Consciousness; Urinary Tract Infection

  MAUDE report 50082753 ↗
• MalfunctionJul 28, 2026Battery Problem; Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058436 ↗
• DeathJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT SUBSEQUENTLY EXPIRED. THE DETAILS FOR THE DEATH WAS NOT AVAILABLE WHEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 25409867 ↗
• DeathMay 28, 2026Disconnection; Pumping Stopped

  IT WAS REPORTED THAT A VENTRICULAR ASSIST DEVICE (VAD) PATIENT REPORTEDLY HAD INCREASED CONFUSION AND WAS FOUND DOWN BY FAMILY WITH NO BATTERIES CONNECTED. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND PRONOUNCED THE PATIENT DECEASED AT THE SCENE.

  Patient problems: Confusion/ Disorientation

  MAUDE report 25321073 ↗
• DeathApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE PATIENT WITH A MEDICAL HISTORY OF CARDIOMYOPATHY PASSED AWAY AT AN OUTSIDE HOSPITAL EMERGENCY DEPARTMENT. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION WILL BE FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24831537 ↗
• DeathApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE PATIENT WITH A MEDICAL HISTORY OF CARDIOMYOPATHY WHO BECAME SEPTIC AND REQUIRED I NTUBATION. THE FAMILY ELECTED PALLIATIVE CARE AND THE VENTRICULAR ASSIST DEVICE WAS TURNED OFF, AND THE PATIENT SUBSEQUENTLY PASSED AWAY.

  Patient problems: Sepsis

  MAUDE report 24820271 ↗

Other Heartware Inc. products

• HeartWare Battery11 models · 4,241 reports · 5 recalls
• HVAD Controller3 models · 2,990 reports · 5 recalls
• HeartWare Controller2 models · 2,393 reports · 3 recalls
• Patient Pack2 models · 224 reports · 2 recalls
• HeartWare Controller AC Adapter5 models · 97 reports · 3 recalls
• HVAD Pump Outflow Graft3 models · 60 reports · 2 recalls
• HVAD Pump Implant Accessories2 models · 2 reports · 3 recalls
• HeartWare Controller DC Adapter6 models · 59 reports · 1 recall