HVAD Pump Implant Kit 1103 (UDI 00888707003261)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,952 adverse event reports that list this exact device (DI 00888707003261), received between Jan 7, 2019 and Sep 28, 2026 — classified as 424 deaths, 2,112 injuries, 416 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (904 reports).

6 FDA recall records name this device's identifier, 6 still open.

56 other recalls cover devices cleared under the same FDA submission (P100047); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 31, 2023Class IIOpen, 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 · Recall details · FDA record ↗

2. Nov 29, 2022Class IIOpen, 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 ↗

3. Mar 30, 2022Class IIOpen, 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 · Recall details · FDA record ↗

4. Jun 3, 2021Class IOpen, 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 ↗

5. Nov 19, 2020Class IOpen, 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 · Recall details · FDA record ↗

6. Apr 3, 2020Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,952 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 28, 2026Battery Problem; Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058436 ↗
• 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 ↗
• DeathMar 12, 2026Electrical /Electronic Property Problem; Pumping Stopped; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT HAVE A DOPPLER SIGNAL, AND NO MEAN ARTERIAL PRESSURE (MAP) OR BLOOD PRESSURE (BP) WAS DETECTED. THE PATIENT PUPILS APPEARED BILATERALLY FIXED/NON-REACTIVE, AND THERE WERE ABSENT BREATH SOUNDS; FROM THE EMERGENCY MEDICAL SERVICES (EMS) CREW'S ASSESSMENT OF THE PATIENT AND HAD LIKELY BEEN DOWN FOR GREATER THAN ONE (1) HOUR. IT WAS NOTED THAT UPON EXCHANGING TO THE BACKUP CONTROLLER THE READING WAS 0.8-0.9L/MIN, AND AFTER ABOUT FIVE (5) MINUTES, THERE WAS STILL NO PERIPHERAL DOPPLER SIGNAL OR NO SIGNS OF LIFE. IT WAS ALSO REPORTED THAT A VAD DISCONNECT OCCURRED AT THE TIME OF THE CONTROLLER EXCHANGE.

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

  MAUDE report 24579600 ↗
• DeathFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPIRED IN HOSPICE DUE TO HEART FAILURE. THE PUMP WAS DISCONTINUED AFTER DEATH.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24365349 ↗
• DeathFeb 6, 2026Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CONTROLLER ALARM OCCURRED WITH THE VENTRICULAR ASSIST DEVICE (VAD) DURING PATIENT TRANSPORT. THE PATIENT CONTACTED A COORDINATOR AND WAS INSTRUCTED TO GO TO THE NEAREST VENTRICULAR ASSIST DEVICE CENTER. UPON ARRIVAL AT THE HOSPITAL, PATIENT DEATH WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24280078 ↗
• MalfunctionFeb 3, 2026Pumping Problem

  A REVIEW OF LOG FILE DATA REVEALED THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED ABOVE NORMAL POWER. 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 24247448 ↗
• InjuryJan 28, 2026Increase in Suction

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS HOSPITALIZED AND UNDERWENT A TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND EXHIBITED A SUCTION ALARM A MONTH POST IMPLANT. THE TTE SHOWED MODERATE RIGHT VENTRICULAR ENLARGEMENT (RVE) WITH SEVERE RIGHT HEART FAILURE AND DYSFUNCTION. THE PATIENT WAS GIVEN INTRAVENOUS (IV) MEDICATION, AND THE PUMP SPEED WAS DECREASED. A SUBSEQUENT TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED ABOUT A YEAR AFTER AND SHOWED A NORMAL RIGHT VENTRICLE WITH MODERATE RIGHT VENTRICULAR DYSFUNCTION. THE VAD REMAINS IMPLANTED NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Unspecified Heart Problem

  MAUDE report 24200465 ↗
• DeathJan 15, 2026Disconnection; Failure to Pump; Pumping Stopped; Battery Problem; Power Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS ADMITTED TO HOSPITAL FOR RESPIRATORY DISTRESS, HYPOTENSION AND LOW FLOWS. DURING THIS HOSPITAL STAY THE PATIENT WAS BEING PREPPED FOR AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) AND AS THE PATIENT WAS BEING CHANGED FROM BATTERY TO WALL POWER A NO-POWER ALARM OCCURRED FOLLOWED BY A VAD STOP ALARM. THE CONTROLLER WAS EXCHANGED TO THE BACK-UP CONTROLLER, WHICH WAS AN ALGORITHM C CONTROLLER AND THE PUMP DID NOT START. A CONTROLLER FROM THE HOSPITAL STOCK, ALSO AN ALGORITHM C CONTROLLER WAS USED AND THE PUMP DID NOT START. PER THE HOSPITAL STAFF THE POWER SOURCE WAS IN PLACE BEFORE DISCONNECTING. REVIEW OF LOG FILE DATA REVEALED ATYPICAL MOTOR START EVENTS. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND SUBSEQUENTLY DIED.

  Patient problems: Low Blood Pressure/ Hypotension; Respiratory Insufficiency

  MAUDE report 24083469 ↗
• DeathJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT DIED OF SEPSIS.

  Patient problems: Sepsis

  MAUDE report 24083326 ↗
• MalfunctionJan 7, 2026Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) HAD A MOTOR START EVENT WITH STARTING PARAMETERS OUTSIDE OF THE TYPICAL RANGE NOTED IN LOG FILES DATA FOLLOWING A ROUTINE CONTROLLER EXCHANGE. 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 23994732 ↗
• MalfunctionDec 17, 2025Pumping Stopped; Use of Device Problem; Pumping Problem; Pumping Stopped; Use of Device Problem; Pumping Problem

  IT WAS REPORTED THAT A REVIEW OF LOG FILE DATA REVEALED A MOTOR START EVENT WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE. IT WAS ALSO REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED HIGH POWER, AND THE PATIENT EXPERIENCED MULTIPLE PUMP STOPS DUE TO DOUBLE POWER DISCONNECTS. THE VAD COORDINATOR REPORTED THAT THE PATIENT IS ELDERLY AND LIKELY PERFORMS DOUBLE POWER DISCONNECTS WHILE CHANGING POWER SUPPLIES, RESULTING IN PUMP STOPS. 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 23832282 ↗
• MalfunctionDec 15, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED ABOVE NORMAL POWER. THE VAD 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 23804650 ↗
• DeathDec 8, 2025Pumping Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 23742045 ↗
• InjuryDec 5, 2025Pumping Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH FLUIDS.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23728666 ↗
• InjuryDec 5, 2025Pumping Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) WHICH REDUCED THE PUMP THROMBUS.

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

  MAUDE report 23728554 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR BLOODY STOOL AND IRON DEFICIENCY ANEMIA. A COLONOSCOPY WAS DONE AND HEMORRHOIDS WERE IDENTIFIED AS THE SOURCE OF THE BLOOD LOSS. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23681459 ↗
• InjuryNov 25, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING A ROUTINE CLINIC VISIT, LOGFILES FROM THE VENTRICULAR ASSIST DEVICE (VAD) WERE REVIEWED AND A LOW FLOW ALARM WAS NOTED. THE PATIENT HAS CHRONIC HYPERTENSION, AND ONGOING ADJUSTMENTS TO MEDICATIONS ARE BEING MADE. LOGFILES WERE SENT AND REVIEWED AS PART OF THE ASSESSMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 23646489 ↗
• InjuryNov 21, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS HOSPITALIZED WITH LOW FLOW ALARMS AND HYPOTENSION. THE PATIENT WAS FOUND TO HAVE A URINARY TRACT INFECTION WITH POSITIVE URINE CULTURE AND WAS TREATED WITH ANTIBIOTICS. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Urinary Tract Infection

  MAUDE report 23619207 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100047. One submission often covers many models, so check the product and lot details in each record.

• Z-0475-2024 · Oct 31, 2023 · Open, Classified
  HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
• Z-1993-2023 · May 16, 2023 · Open, Classified
  HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
• Z-1512-2022 · Jun 28, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
• Z-1266-2022 · May 5, 2022 · Open, Classified
  HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
• Z-1207-2022 · Apr 14, 2022 · Open, Classified
  HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
• Z-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• Z-1107-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• Z-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-0726-2022 · Jan 27, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System
• Z-2478-2021 · Aug 6, 2021 · Open, Classified
  Medtronic HVAD Pump Implant Kits
• Z-2190-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1125
• Z-2195-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Implant Kit, REF MCS1705PU

…and 41 more.