HVAD® Pump Implant Kit 1103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,737 adverse event reports that list this exact device (DI 00888707002639), received between Aug 25, 2017 and Sep 29, 2026 — classified as 666 deaths, 1,532 injuries, 539 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (1,017 reports).

4 FDA recall records name this device's identifier, 4 still open.

57 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. 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 ↗

3. 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 ↗

4. 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 2,737 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• DeathApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS ON PALLIATIVE CARE AND PASSED AWAY IN HOSPICE. THE SITE DID NOT WISH TO PROVIDE FURTHER DETAILS AND NO CAUSE OF DEATH WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24775457 ↗
• DeathMar 16, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT CUT THE DRIVELINE, AND 911 WAS CALLED. THE PATIENT WAS PRONOUNCED DECEASED OUTSIDE OF THE HOSPITAL EMERGENCY ROOM.

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

  MAUDE report 24606590 ↗
• DeathFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENTRICULAR ASSIST DEVICE (VAD) PATIENT PRESENTED WITH NONISCHEMIC CARDIOMYOPATHY, CHRONIC EXTERNAL DRIVELINE (DL) INFECTION, STROKE, DEPRESSION, ANXIETY, WORSENING HEART FAILURE, ATRIAL FLUTTER, ACUTE KIDNEY INJURY, AND GASTROINTESTINAL PAIN. THE PATIENT WAS ADMITTED WITH THESE SYMPTOMS AND WEIGHED 58KG AT ADMISSION. ANTICOAGULATION WAS HELD AND CARDIOVERSION DEFERRED BOTH DUE TO HISTORY OF INTRACRANIAL BLEED. CULTURES AND BLOOD CULTURES WERE CONDUCTED AND REVEALED SERRATIA BACTEREMIA (BACTERIA FOUND IN THE BLOODSTREAM), RECURRENT CANDIDA LUSITANIAE FUNGEMIA DESPITE THERAPY. THE PATIENT WAS MANAGED WITH ANTIBIOTICS, INCLUDING MEROPENEM AND MICAFUNGIN, AND FLUCYTOSINE WAS ADDED DURING THIS ADMISSION. INOTROPIC SUPPORT WITH DOBUTAMINE AND INTRAVENOUS DIURESIS WAS ALSO PROVIDED. THE PATIENT EXPERIENCED BREAKTHROUGH SEIZURES, INCREASING SOMNOLENCE, RESPIRATORY DISTRESS, AND WAS MALNOURISHEDWITH A FINAL WEIGHT OF 50KG. COMFORT MEASURES WERE INITIATED AFTER FURTHER DECLINE. THE PATIENT SUBSEQUENTLY EXPIRED DUE TO CARDIOGENIC SHOCK.

  Patient problems: Anxiety; Atrial Flutter; Bacterial Infection; Cardiogenic Shock; Convulsion/Seizure; Depression; Fungal Infection; Heart Failure/Congestive Heart Failure; Kidney injury; Pain; Respiratory Insufficiency; Stroke/CVA

  MAUDE report 24345313 ↗
• DeathFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENTRICULAR ASSIST DEVICE (VAD) PATIENT EXPERIENCED DECOMPENSATED HEART FAILURE, GASTROINTESTINAL BLEED, AND FAILURE TO THRIVE. THE PATIENT WAS SUBSEQUENTLY TRANSITIONED TO HOSPICE AND DEATH OCCURRED.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24337371 ↗
• DeathFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR ASSIST DEVICE (VAD), EXPERIENCED MULTIPLE FALLS AT HOME AND SUBSEQUENTLY PRESENTED WITH RIGHT SIDED WEAKNESS AND APHASIA. THE PATIENT WAS FOUND TO HAVE A SUBDURAL HEMATOMA, WHICH WAS EVACUATED, FOLLOWED BY AN EMERGENT RETURN TO THE OPERATING ROOM FOR AN EPIDURAL HEMATOMA. IMAGING SUGGESTED PROGRESSIVE MULTICOMPARTMENTAL INTRACRANIAL HEMORRHAGES. THE PATIENT EXHIBITED COGNITIVE DECLINE AND NEUROLOGICAL DYSFUNCTION DURING HOSPITALIZATION. LABORATORY TESTING REVEALED A SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO OF 0.9 ON ADMISSION, AND THE PATIENT WAS NOTED TO BE NON-ADHERENT WITH INTERNATIONAL NORMALIZED RATIO CHECKS AND OFFICE VISITS. HEART FAILURE WAS IDENTIFIED AS A RISK FACTOR. COMPUTED TOMOGRAPHY OF THE BRAIN/HEAD AND INTERNATIONAL NORMALIZED RATIO LAB TESTING WERE CONDUCTED. THE PATIENT WAS ADMITTED AND MONITORED. VENTRICULAR ASSIST DEVICE SUPPORT WAS DISCONTINUED IN THE NEURO INTENSIVE CARE UNIT, AND THE PATIENT DIED.

  Patient problems: Dysphasia; Fall; Heart Failure/Congestive Heart Failure; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Unspecified Nervous System Problem

  MAUDE report 24308621 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CARDIOMYOPATHY AND AN IMPLANTED VENTRICULAR ASSIST DEVICE PRESENTED WITH SHORTNESS OF BREATH AND TIREDNESS. ELECTROCARDIOGRAM AND LOG FILE REVIEW CONFIRMED CARDIAC ARRHYTHMIA, SPECIFICALLY VENTRICULAR TACHYCARDIA. THE PATIENT UNDERWENT CARDIOVERSION AND RECEIVED ANTIARRHYTHMIC MEDICATION (AMIODARONE); HOWEVER, VENTRICULAR TACHYCARDIA RECURRED AND ONGOING TREATMENT WITH AMIODARONE WAS PROVIDED. THE VAD REMAINS IN USE.

  Patient problems: Arrhythmia; Dyspnea; Tachycardia

  MAUDE report 24260893 ↗
• DeathJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR ASSIST DEVICE WAS FOUND DECEASED, WITH THE CAUSE OF DEATH UNKNOWN. PATIENT SYMPTOMS AND COMPLICATIONS WERE REPORTED AS UNKNOWN, AND THERE WERE NO SPECIFIC SIGNS, SYMPTOMS, OR PROCEDURAL OR DEVICE-RELATED ISSUES DETAILED. .

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

  MAUDE report 24184548 ↗
• DeathJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS TAKEN OFF VAD SUPPORT AT THE REQUEST OF THE FAMILY AND THE PATIENT SUBSEQUENTLY DIED.

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

  MAUDE report 24133648 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) BACTEREMIA, DRIVELINE INFECTION AS WELL AS END STAGE ISCHEMIC CARDIOMYOPATHY.

  Patient problems: Bacteremia; Bacterial Infection; Cardiomyopathy; Multiple Organ Dysfunction Syndrome; Sepsis; Unspecified Infection

  MAUDE report 24052334 ↗
• DeathJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS NOT FEELING WELL WAS BROUGHT TO HOSPITAL IN CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION WITH THE LUCAS (LUND UNIVERSITY CARDIOPULMONARY ASSIST SYSTEM) DEVICE ON. THE PATIENT WAS IN CARDIAC STANDSTILL AND SUBSEQUENTLY DIED. THE CAUSE OF CARDIAC ARREST AND SUBSEQUENT DEATH IS UNKNOWN.

  Patient problems: Cardiac Arrest

  MAUDE report 23961165 ↗
• DeathJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR ASSIST DEVICE EXPERIENCED MULTI ORGAN SYSTEM FAILURE AND FAILURE TO THRIVE, WHICH RESULTED IN DEATH. THE EVENT WAS NOT RELATED TO THE DEVICE OR THE IMPLANT PROCEDURE ACCORDING TO THE TREATING PHYSICIAN'S MEDICAL OPINION. NO DEVICE MALFUNCTION, PROCEDURAL ISSUE, INFECTION, OR ALLEGATION AGAINST THE DEVICE WAS REPORTED. NO TESTING OR IMAGING RESULTS WERE PROVIDED.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 23959036 ↗
• InjuryJan 2, 2026Pumping Stopped; Material Integrity Problem; Power Problem; Pumping Problem

  IT WAS REPORTED THAT THE PATIENT HAD HAD A DRIVELINE STRAIN RELIEF REPAIR AND THE REPAIR "FELL OFF". THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED CONTINUOUS HIGH WATT AND ELECTRICAL FAULT ALARMS. THE PATIENT WAS ADMITTED AND SERVICING WAS PERFORMED, AND IT WAS FOUND THAT THE PREVIOUS REPAIR TO RECREATE THE STRAIN RELIEF WAS MISSING AND THERE WAS A BREAK IN THE DRIVELINE RIGHT NEXT TO THE CONNECTOR NUT. THE WIRES WERE INTACT. LOG FILE REVIEW ALSO REVEALED MULTIPLE LOW FLOW ALARMS AND A VAD STOP ASSOCIATED WITH AN UNEXPECTED LOSS OF POWER TO THE CONTROLLER. IT WAS STATED THAT THE LOW FLOW ALARMS WERE RELATED TO THE PATIENT NOT TAKING ENOUGH FLUIDS; THE PATIENT WAS ENCOURAGED TO DRINK MORE FLUIDS. IT WAS ALSO STATED THAT THE VAD STOP WAS LIKELY DONE INTENTIONALLY BY THE PATIENT. THE SAME DAY THE PATIENT HAD TAKEN PILLS IN AN ATTEMPT TO COMMIT SUICIDE. THE PATIENT WAS ADMITTED TO THE HOSPITAL, EVALUATED BY PSYCHIATRY AND DISCHARGED. THE VAD WAS NOT INTERROGATED AT THAT TIME AND THE PATIENT DID NOT TELL STAFF THAT THE VAD HAD BEEN DISCONNECTED. THE VAD AND CONTROLLER REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Suicidal Ideation

  MAUDE report 23944083 ↗
• MalfunctionJan 2, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE CABLE HAD DAMAGE TO A PRIOR SHEATH REPAIR. IT WAS OBSERVED THAT THE PRIOR REPAIR HAD BROKEN DOWN AND HAD DISCONTINUITIES, WHICH WAS ATTRIBUTED TO NORMAL WEAR AND TEAR AS THE PATIENT WAS ACTIVE. DRIVELINE SHEATH REPAIR SERVICING WAS COMPLETED. 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 23944051 ↗
• MalfunctionDec 30, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED MULTIPLE LOW FLOW ALARMS. 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 23923819 ↗
• DeathDec 18, 2025Pumping Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE VAD PATIENT HAD A SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) DUE TO THE SUBARACHNOID BLEED WHICH MAY HAVE BEEN THE CAUSE OF A THE POTENTIAL OCCLUSION. ANTICOAGULANTS HAD BEEN DISCONTINUED DUE TO THE BLEED. THE PATIENT HAD WORSENING HEART FAILURE AND WAS ON INTRAVENOUS (IV) MEDICATIONS TO STABILIZE BLOOD PRESSURE AND BIPAP (BILEVEL POSITIVE AIRWAY PRESSURE). A CORONARY ANGIOGRAM AND COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE DONE. THE PATIENT WAS IN ACUTE RENAL FAILURE, WORSENING RIGHT VENTRICLE FAILURE AND WAS ULTIMATELY PLACED ON COMFORT MEASURES. THE PATIENT SUBSEQUENTLY DIED AND THE CAUSE OF DEATH WAS RIGHT HEART FAILURE.

  Patient problems: Coagulation Disorder; Convulsion/Seizure; Heart Failure/Congestive Heart Failure; Intracranial Hemorrhage; Low Blood Pressure/ Hypotension; Renal Failure

  MAUDE report 23842869 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE UPPER RESPIRATORY INFECTION WAS NOT DEVICE RELATED AND THERE WERE NO VAD COMPLICATIONS.

  Patient problems: Discomfort; Respiratory Tract Infection

  MAUDE report 23839511 ↗
• InjuryDec 15, 2025Battery Problem; Connection Problem; Material Integrity Problem; Power Problem; Pumping Problem; Battery Problem; Connection Problem; Material Integrity Problem; Power Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE LOSSES OF POWER ON THE CONTROLLER WERE ATTRIBUTED TO POWER SWITCHING AND POWER DISCONNECTS. THE BATTERIES WERE EXCHANGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805182 ↗
• DeathDec 4, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOW FLOWS ON THE VENTRICULAR ASSIST DEVICE (VAD) WHICH WERE ATTRIBUTED TO A GASTROINTESTINAL BLEED (GIB) AND HYPOVOLEMIA/HYPOTENSION. AN UPPER ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED THAT SHOWED A NONBLEEDING GASTRIC ULCER AROUND THE PATIENT'S PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) SITE. THE PATIENT'S HEMOGLOBIN WAS 6.3 ON ADMISSION AND IT WAS NOTED THAT THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS THERAPEUTIC. THE PATIENT WAS TREATED WITH A TRANSFUSION OF PACKED RED BLOOD CELLS (PRBC). THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemia; Low Blood Pressure/ Hypotension

  MAUDE report 23720222 ↗
• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS ALSO REPORTED THAT THE DL WAS INSPECTED AND THE SMALL BREAK WAS FOUND APPROXIMATELY 5 INCHES FROM THE STRAIN RELIEF AT THE CONTROLLER END OF THE DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681624 ↗
• MalfunctionDec 1, 2025Use of Device Problem; Power Problem; Pumping Problem; Use of Device Problem; Power Problem; Pumping Problem

  IT WAS REPORTED THAT REVIEW OF LOG FILE DATA REVEALED HISTORY A MOTOR START EVENT WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE THAT OCCURRED ON (B)(6) 2025. THE EVENT WAS ASSOCIATED WITH AN ACCIDENTAL DOUBLE POWER DISCONNECT WHILE THE PATIENT WAS EXCHANGING POWER SOURCES DURING A MOMENT OF CONFUSION. THE PUMP SUCCESSFULLY STARTED ON THE FIRST ATTEMPT; HOWEVER, THE RECORDED POWER, VOLTAGE, AND CURRENT VALUES WERE ABOVE THE NORMAL OPERATING RANGE. THE PATIENT WAS INSTRUCTED TO CHANGE POWER SOURCES ONE AT A TIME TO PREVENT REPEATED POWER INTERRUPTIONS. THE VENTRICULAR ASSIST DEVICE (VAD) AND CONTROLLER REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Confusion/ Disorientation

  MAUDE report 23681500 ↗

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-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-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-2196-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Outflow Graft, REF MCS1725OG
• Z-2189-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1104

…and 42 more.