HVAD® Pump Implant Kit (Enhanced) 1103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,807 adverse event reports that list this exact device (DI 00888707000017), received between Jan 26, 2015 and Sep 23, 2026 — classified as 573 deaths, 1,368 injuries, 866 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (979 reports).

4 FDA recall records name this device's identifier, 4 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, 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. Feb 26, 2021Class IIOpen, 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 ↗

2. Feb 26, 2021Class IIOpen, 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 ↗

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 2,807 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Increase in Suction; Pumping Problem

  The ventricular assist device (VAD) patient was admitted to the hospital with fatigue, acute kidney injury (AKI), anemia, and hypovolemia. A review of the log-file data revealed motor-start events with parameters outside the typical range. The log-file review also showed low-flow alarms and suction events with worsening trends. Additional review identified unexpected power-loss events. The patient has a history of motor-start events associated with accidental double power disconnects. The patient reported that they may have accidentally disconnected the device again but were unsure. Based on the available log-file data and the patient's history, the VAD team suspects that an accidental power disconnection is the most likely explanation for the unexpected power-loss and motor-start events. The patient was treated with volume resuscitation. The VAD remains in use, and no further patient complications have been reported as a result of this event.

  Patient problems: Anemia; Fatigue; Hypovolemia; Kidney injury

  MAUDE report 50870859 ↗
• InjuryJul 30, 2026Battery Problem; Pumping Problem

  It was reported that the Ventricular Assist Device (VAD) exhibited low-flow events, and the patient experienced hypertension. Additionally, the controller exhibited a Controller Fault alarm due to internal battery end-of-life. The controller was exchanged, and the VAD remains in use.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 50082463 ↗
• DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR AN ISCHEMIC STROKE AND WAS TREATED WITH THROMBOLYTIC THERAPY. THE STROKE THEN BECAME HEMORRHAGIC AFTER THROMBOLYTICS WERE ADMINISTERED, COMFORT CARE MEASURES WERE INITIATED, AND THE PATIENT EXPIRED. THE VENTRICULAR ASSIST DEVICE REMAINS IMPLANTED.

  Patient problems: Intracranial Hemorrhage; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 25448592 ↗
• DeathMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENTRICULAR ASSIST DEVICE (VAD) PATIENT EXPERIENCED SEPSIS AND PNEUMONIA AND SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS NOTED AS COMPLICATIONS RELATED TO SEPSIS AND PNEUMONIA.

  Patient problems: Pneumonia; Sepsis

  MAUDE report 24533666 ↗
• DeathFeb 26, 2026Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) OUTFLOW GRAFT HAD A SUSPECTED OCCLUSION. THE PATIENT UNDERWENT A LEFT THORACOTOMY TO REVISE THE OUTFLOW GRAFT. THE PATIENT EXPERIENCED A STROKE POST-OPERATION AND SUBSEQUENTLY DIED DUE TO CARDIAC ARREST. THE VAD AND OUTFLOW GRAFT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Cardiac Arrest; Obstruction/Occlusion; Stroke/CVA

  MAUDE report 24456061 ↗
• DeathFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED DUE TO MULTIFOCAL PNEUMONIA AND DECOMPENSATED HEART FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure; Pneumonia

  MAUDE report 24314241 ↗
• DeathFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED AT HOME UNDER HOSPICE CARE DUE TO MENTAL DECLINE.

  Patient problems: Dysphasia; High Blood Pressure/ Hypertension; Lethargy; Stroke/CVA; Thrombosis/Thrombus; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Nervous System Problem

  MAUDE report 24273702 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR ASSIST DEVICE (VAD) PRESENTED WITH RIGHT SHOULDER PAIN, AND AN ELEVATED LACTIC DEHYDROGENASE (LDH) LEVEL OF 1200. THERE WAS POSSIBLE CONCERN FOR THROMBUS FORMATION. THE LDH LABORATORY TESTING WAS CONDUCTED, CONFIRMING THE ELEVATED RESULT. THE VAD REMAINS IN USE.

  Patient problems: Lactate Dehydrogenase Increased; Pain; Thrombosis/Thrombus

  MAUDE report 24250889 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENTRICULAR ASSIST DEVICE (VAD) PATIENT DEVELOPED AN ABSCESS ON THE STERNUM OVER THE PAST MONTH WHICH BECAME ACUTE OVER THE WEEKEND. STERNAL WIRES HAD BEEN REMOVED FROM THE TIME OF IMPLANT AROUND A YEAR AGO. THE PATIENT WAS HOSPITALIZED WITH A LOCALIZED BACTERIAL INFECTION IN THE MEDIASTINUM, BLOOD CULTURES WERE DRAWN AND CONFIRMED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PATIENT WAS TREATED WITH ANTIBIOTICS, AND A WOUND VAC WAS PLACED. THE PATIENT WAS DISCHARGED HOME ON ANTIBIOTICS. THE VAD REMAINS IN USE.

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 24202669 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENTRICULAR ASSIST DEVICE (VAD) PATIENT PRESENTED WITH LEFT ARM PARALYSIS AND EXPRESSIVE APHASIA. THE PATIENT WAS FOUND TO HAVE NEUROLOGICAL DYSFUNCTION, SPECIFICALLY A RIGHT MIDDLE CEREBRAL ARTERY STROKE (MCA). COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN/HEAD WAS PERFORMED. THE PATIENT WAS ON ANTICOAGULANT AND ASPIRIN THERAPY, WITH THERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) ON ADMISSION. THE WEEK PRIOR IT WAS 1.8. A THROMBECTOMY WAS PERFORMED ONCE THE MCA WAS DIAGNOSED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SOME LEFT ARM WEAKNESS BUT REGAINED FUNCTION FOR THE MOST PART. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE PATIENT IS MONITORED AND STABLE. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy; Paralysis; Speech Disorder; Stroke/CVA; Unspecified Nervous System Problem

  MAUDE report 24202391 ↗
• DeathJan 15, 2026Electrical /Electronic Property Problem; Pumping Stopped; Material Too Rigid or Stiff; Battery Problem; Contamination /Decontamination Problem; Material Integrity Problem; Power Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT WHILE THE PATIENT WAS HOSPITALIZED EXPERIENCED LEFT SIDED WEAKNESS - FACIAL DROOP AND ARM WEAKNESS, A C OMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WITH NO FINDINGS. A WEEK LATER THE PATIENT BECAME UNRESPONSIVE REQUIRING INTUBATION, CT WAS REPEATED AND SHOWED AN ISCHEMIC STROKE WITH MIDLINE SHIFT, NO INTERVENTIONS WERE PLANNED. THE VAD WAS TURNED OFF AND THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS STROKE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ischemia Stroke; Muscle Weakness/Atrophy

  MAUDE report 24089462 ↗
• InjuryDec 16, 2025Use of Device Problem; Battery Problem; Power Problem; Pumping Problem; Use of Device Problem; Battery Problem; Power Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT A REVIEW OF LOG FILES DATA REVEALED A LOSS OF POWER TO THE CONTROLLER HAD OCCURRED. THE NIGHT NURSE DISCONNECTED THE BATTERIES IN ERROR. REEDUCATION WAS PROVIDED TO THE STAFF.

  Patient problems: Dehydration

  MAUDE report 23817749 ↗
• InjuryDec 12, 2025Disconnection; Battery Problem; Power Problem; Pumping Problem; Disconnection; Battery Problem; Power Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED AND THAT THE DIURETIC MEDICATIONS WERE ADJUSTED FOR THE HYPOVOLEMIA.

  Patient problems: Hypovolemia

  MAUDE report 23789114 ↗
• DeathDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR ASSIST DEVICE EXPERIENCED A FRONTAL LOBE CEREBROVASCULAR ACCIDENT (STROKE) WHILE ON A CRUISE SHIP. THE PATIENT ENTERED INTO HOSPICE CARE AND SUBSEQUENTLY PASSED AWAY.

  Patient problems: Stroke/CVA

  MAUDE report 23757665 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS TRAUMA TO THE DRIVELINE SITE AND AN INFECTION DEVELOPED. THE INFECTION WAS TREATED WITH A BRIEF COURSE OF ANTIBIOTICS AND RESOLVED. THE DRIVELINE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Tissue Injury

  MAUDE report 23756430 ↗
• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OLD SHEATH REPAIR FROM (B)(6) 2023. IT WAS FRAYING, BUT THERE WERE NO CRACKED AREAS EXPOSED. THE OLD REPAIR WAS REMOVED, AND THE DRIVELINE WAS ASSESSED AND PHOTOGRAPHED. A NEW REPAIR WAS PERFORMED, COVERING ALL THE CRACKS. THE DRIVELINE COVER WAS ABLE TO MOVE FREELY BACK AND FORTH AFTER REPAIR. THE DRIVELINE 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 23681640 ↗
• MalfunctionNov 25, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED ABOVE NORMAL POWER CONSUMPTION. THE PATIENT WAS SEEN IN CLINIC AND NO COMPLICATIONS OR CHANGES WERE MADE, WITH NO RECENT ALARMS NOTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646803 ↗
• MalfunctionNov 20, 2025Increase in Suction; Pumping Problem; Increase in Suction; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED ABOVE NORMAL POWER CONSUMPTION AND SUCTION 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 23610279 ↗
• MalfunctionNov 14, 2025No Audible Alarm; Display or Visual Feedback Problem; Pumping Stopped; Battery Problem; Power Problem; No Audible Alarm; Display or Visual Feedback Problem; Pumping Stopped; Battery Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE VAD EXHIBITED A VAD DISCONNECT ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555974 ↗
• MalfunctionNov 14, 2025Use of Device Problem; Power Problem; Pumping Problem; Use of Device Problem; Power Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE LOSS OF POWER OCCURRED DUE TO A DOUBLE POWER DISCONNECT. THE PATIENT WAS EDUCATED ON PROPER POWER SOURCE CHANGES. THE CONTROLLER REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555305 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT INITIALLY PRESENTED AFTER SYNCOPE AND COLLAPSE. INFECTIOUS DISEASE WAS CONSULTED AND THE PATIENT WAS STARTED ON INTRAVENOUS (IV) ANTIBIOTICS. A COLONOSCOPY, ECHOCARDIOGRAM, POSITRON EMISSION TOMOGRAPHY (PET) SCAN AND COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE PERFORMED.

  Patient problems: Bacteremia; Fall; Syncope/Fainting

  MAUDE report 23497200 ↗
• InjuryNov 6, 2025Pumping Stopped; Use of Device Problem; Power Problem; Pumping Problem; Pumping Stopped; Use of Device Problem; Power Problem; Pumping Problem

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR ASSIST DEVICE (VAD) EXPERIENCED LOW FLOW ALARMS AND A VAD STOPPED ALARM. THE PATIENT WAS ON VACATION AND VISITED A MEDICAL FACILITY, WHERE THE HEMATOCRIT (HCT) WAS CHANGED TO 50%, RESULTING IN LOW FLOW ALARMS DUE TO THE CHANGE IN FLOW. THE HEMATOCRIT WAS CHANGED AGAIN, BUT THE LOW FLOW ALARM LIMIT DID NOT APPEAR TO BE ADJUSTED TO REFLECT THE PATIENT'S NEW BASELINE. LOGFILES WERE REVIEWED AND DEMONSTRATED THE VAD STOPPED ALARM. INITIAL NURSING STAFF REPORTS DID NOT IDENTIFY A CAUSE FOR THE STOP ALARM; HOWEVER, IT WAS LATER REPORTED THAT THE PATIENT WAS WALKING AROUND THE ROOM WITH THE CONTROLLER HANGING FROM THE DRIVELINE, WHICH WAS BELIEVED TO HAVE CAUSED THE STOPPED ALARM. IT WAS ALSO REPORTED THAT THE CONTROLLER EXHIBITED MULTIPLE LOSSES OF POWER. 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; Unspecified Nervous System Problem

  MAUDE report 23487459 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENTRICULAR ASSIST DEVICE (VAD) PATIENT PRESENTED WITH CONFUSION, LETHARGY, AND POOR ORAL INTAKE AND WAS ADMITTED TO HOSPITAL. THE PATIENT WAS FOUND TO HAVE A SUPRATHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR), HYPOVOLEMIA, AND A LOCALIZED BACTERIAL URINARY TRACT INFECTION (UTI). THE PATIENT HAD A CHRONIC URINARY CATHETER WHICH WAS CHANGED DURING THE HOSPITALIZATION. DIAGNOSTIC TESTING INCLUDED URINE CULTURES AND LAB TEST. THE INR WAS INITIALLY 12 WHICH WAS TREATED WITH INTRAVENOUS (IV) VITAMIN KAND 1 UNIT OF FRESH FROZEN PLASMA RESULTING IN AN INR OF 1.9. THE PATIENT RECEIVED ANTIBIOTICS AND IV FLUIDS FOR TREATMENT OF THE INFECTION AND HYPOVOLEMIA. ONCE THE INR WAS WITHIN THE NORMAL RANGE THE PATIENT WAS BRIDGED WITH AN ANTICOAGULANT DRIP AND STARTED ON ORAL ANTICOAGULANTS. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY. THE VAD REMAINS IN USE.

  Patient problems: Bacterial Infection; Coagulation Disorder; Confusion/ Disorientation; Hypovolemia; Lethargy; Urinary Tract Infection

  MAUDE report 23486558 ↗
• MalfunctionNov 4, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING A ROUTINE CLINIC VISIT AN ATTEMPT TO UPDATE THE CONTROLLER AND MONITOR INFORMATION AS PREVIOUS LOG FILES WERE IN ACCURATE. THE MONITOR USED WAS NOT WORKING CORRECTLY AND REPEATEDLY DISPLAYED A RED BATTERY ALERT. PREVIOUS LOG FILES WERE FOUND TO BE INACCURATE, SHOWING THE WRONG HARDWARE SERIAL NUMBER, WRONG CONTROLLER NUMBER, AND INCORRECT DATE. DURING AN ATTEMPT TO UPDATE THE CONTROLLER AND MONITOR INFORMATION, THE MONITOR MALFUNCTIONED AGAIN DURING DATA DOWNLOAD. VAD LOGS AND NEW LOG FILES WERE SUBMITTED AND REVIEWED DURING THE CLINIC VISIT. DESPITE REPROGRAMMING THE CONTROLLER INFORMATION, THE REPORT CONTINUED TO DISPLAY OUTDATED AND INCORRECT DETAILS. A NEW MONITOR WAS USED FOR SUBSEQUENT DATA DOWNLOADS. THE VAD REMAINS IN USE, AND THE MONITOR WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467028 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS BROUGHT TO THE HOSPITAL WITH NECROTIZING FASCIITIS OF THE RIGHT LEG. THE PATIENT¿S WHITE BLOOD CELL (WBC) COUNT WAS 40, AND THE FOOT WAS NECROTIC WITH A SEVERE ODOR. THE PATIENT UNDERWENT AN ABOVE-THE-KNEE AMPUTATION, AS THE INITIAL WOUND ORIGINATED FROM THE HEEL AND THE INFECTION HAD SPREAD UP THE LEG. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Necrosis; Wound Odor

  MAUDE report 23466913 ↗