HVAD® Pump Implant Kit MCS1705PU (UDI 00888707005364)Recalls & reported problems

Summary

The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 00888707005364), received between Feb 10, 2021 and Jul 30, 2026 — classified as 36 deaths, 117 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (84 reports).

7 FDA recall records name this device's identifier, 7 still open.

54 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-0483-2024 · Root cause: Labeling design · Recall details · FDA record ↗

2. Apr 14, 2022Class IOpen, 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 · 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-2195-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

5. 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 ↗

6. 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 ↗

7. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 203 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• DeathMar 23, 2026Failure to Pump; Pumping Stopped; Battery Problem; Connection Problem; Power Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT EXPERIENCED CARDIAC ARREST FOLLOWING MALFUNCTION OF THE VAD. ACCORDING TO THE SITE, A CONTROLLER EXCHANGE WAS ATTEMPTED BUT THE PUMP DID NOT RESTART; AFTER CHANGING TO ANOTHER CONTROLLER, THE PUMP RESTARTED. MULTIPLE CONTROLLERS WERE EXCHANGED AND EXHIBITED LOSS OF POWER TO THE CONTROLLERS. REVIEW OF LOG FILE DATA REVEALED LOW FLOWS, MULTIPLE MOTOR START EVENTS AND VAD DISCONNECTS. THERE WAS ALSO A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY. THE PATIENT SUBSEQUENTLY DIED DUE TO VAD MALFUNCTION.

  Patient problems: Cardiac Arrest

  MAUDE report 24665911 ↗
• InjuryJan 13, 2026Pumping Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERTENSION AND THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOWS. THE PATIENT WAS KNOWN TO BE NON-COMPLIANT AND INCONSISTENT WITH ALL OF THEIR MEDICATIONS. THE PATIENT'S BLOOD PRESSURE MEDICATIONS WERE ADJUSTED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 24057099 ↗
• InjuryNov 13, 2025No Audible Alarm; Material Discolored; Electrical /Electronic Property Problem; Leak/Splash; Pumping Stopped; Increase in Suction; Battery Problem; Power Problem; No Audible Alarm; Material Discolored; Electrical /Electronic Property Problem; Leak/Splash; Pumping Stopped; Increase in Suction; Battery Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AFTER BEING FOUND VERY CONFUSED. IT WAS FOUND THAT THE VENTRICULAR ASSIST DEVICE (VAD) WAS OFF, THE CONTROLLER WAS NOT MAKING NOISE, AND BOTH BATTERIES WERE COMPLETELY DRAINED. THE BATTERIES WERE REPLACED AND THE VAD IMMEDIATELY RESTARTED. REVIEW OF LOG FILES DATA SHOWED CRITICAL BATTERY ALARMS LEADING TO A CONTROLLER FAULT ALARM. IT WAS ALSO NOTED THAT THE PATIENT HAD SLIGHTING ELEVATED LACTATE DEHYDROGENASE (LDH) AND A LOW INTERNATIONAL NORMALIZED RATIO (INR). WHILE IN THE EMERGENCY DEPARTMENT, IT WAS ALSO REPORTED THAT "BLOOD" WAS OBSERVED WITHIN THE DRIVELINE. THE "BLOOD" WAS SUSPECTED TO BE DISCOLORATION OF THE DRIVELINE SHEATH, WITH FLUID INSIDE THE DRIVELINE. THE PATIENT WAS TRANSFERRED TO THEIR HOSPITAL FOR FURTHER EVALUATION. THE VAD AND CONTROLLER REMAIN IN USE.

  Patient problems: Bacterial Infection; Bladder Dysfunction; Confusion/ Disorientation; Sepsis; Urinary Tract Infection

  MAUDE report 23543791 ↗
• InjuryNov 12, 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 (VAD) EXPERIENCED A DRIVELINE (DL) INFECTION. DRIVELINE CULTURE IDENTIFIED ACTINOMYCES NEUII, WHILE BLOOD CULTURES WERE NEGATIVE. THE PATIENT WAS ADMITTED AND TREATED WITH AN ANTIBIOTIC, THEN DISCHARGED ON ORAL ANTIBIOTICS. THE VAD DL REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 23534812 ↗
• MalfunctionNov 10, 2025Electrical /Electronic Property Problem; Pumping Stopped; Device Fell; Electrical /Electronic Property Problem; Pumping Stopped; Device Fell

  IT WAS FURTHER REPORTED THAT NO SERVICING WAS PERFORMED. THE DL COVER WAS REMOVED BY THE SITE DURING THE CONTROLLER EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513555 ↗
• InjuryJul 31, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOW ALARMS. THE PATIENT SUBSEQUENTLY UNDERWENT A VAD EXCHANGE PROCEDURE. THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REP ORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22679898 ↗
• InjuryJul 22, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOW ALARMS. IT WAS NOTED THAT IT WAS BELIEVED THAT THE LOW FLOW ALARMS WERE RELATED TO BLOOD PRESSURE MEDICATION CHANGES. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: High Blood Pressure/ Hypertension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566110 ↗
• MalfunctionJul 17, 2025Adverse Event Without Identified Device or Use Problem; Pumping Problem; Adverse Event Without Identified Device or Use Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS ADMITTED FROM THE EMERGENCY ROOM (ED) AFTER SYNCOPE AT HOME. THE PATIENT REMAINED IMPATIENT FOR SEVERAL DAYS DUE TO LOWER FLOWS. THE PATIENT RECEIVED INTRAVENOUS (IV) FLUIDS. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22529062 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT ALSO HAD FLUID OVERLOAD AND WAS FOUND TO BE IN ATRIAL FLUTTER.

  Patient problems: Anemia; Arrhythmia; Atrial Flutter; Dyspnea; Hypervolemia

  MAUDE report 22510931 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH RECURRENT FEVER AND STREPTOCOCCUS SANGUINIS BACTEREMIA. A POSITRON EMISSION (PET) COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THE INFECTION IN AND AROUND THE STERNAL WOUND AND DRIVELINE. THE PATIENT UNDERWENT STERNAL DEBRIDEMENT AND WOUND VAC PLACEMENT AS WELL AS STARTING ORAL AND INTRAVENOUS (IV) ANTIBIOTICS. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE.

  Patient problems: Bacteremia; Fever

  MAUDE report 22461964 ↗
• InjuryJul 9, 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 WAS TRANSFERRED FROM THE VAD CLINIC TO THE EMERGENCY DEPARTMENT (ED) DUE TO CONCERNS ABOUT A STERNAL INFECTION RELATED TO A DRIVELINE (DL) INFECTION. THE INFECTION, WAS LOCATED IN THE DL POCKET. THE PATIENT PRESENTED WITH INCREASED SHORTNESS OF BREATH (SOB), VOMITING, AND TENDERNESS NEAR THE STERNUM. UPON ADMISSION, THE PATIENT RECEIVED TREATMENT FOR A STERNAL ABSCESS WITH INTRAVENOUS (IV) ANTIBIOTICS AND UNDERWENT WOUND VACUUM (VAC) THERAPY. THE PATIENT WAS DISCHARGED ONE MONTH LATER. THE VAD REMAINS IN USE, AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Medical device site infection; Pain; Vomiting

  MAUDE report 22457455 ↗
• InjuryJul 8, 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 ADMITTED TO THE HOSPITAL WITH NAUSEA, VOMITING, COUGH AND CHEST PAIN AFTER COMING BACK FROM A CRUISE. THE PATIENT TESTED POSITIVE FOR RHINO ENTEROVIRUS, AND WAS TREATED WITH MEDICATION WHILE INPATIENT. THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Cough; Nausea; Viral Infection; Vomiting

  MAUDE report 22445044 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FEVER AND SHORTNESS OF BREATH. THE PATIENT WAS FOUND TO HAVE A DRIVELINE INFECTION AND STREPTOCOCCUS SANGUINIS BACTEREMIA AND WAS TREATED WITH ANTIBIOTICS VIA PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED TO A SKILLED NURSING FACILITY. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Dyspnea; Fever

  MAUDE report 22437656 ↗
• DeathJun 27, 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 DIED, WITH THE CAUSE OF DEATH UNKNOWN. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information; Pneumonia

  MAUDE report 22344728 ↗
• DeathJun 19, 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 (VAD) WAS MADE COMFORT CARE ONLY AND PASSED AWAY DUE TO HEART FAILURE. THE VAD REMAINS IMPLANTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22293874 ↗
• InjuryJun 10, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOWS AND POWER BELOW NORMAL FOR THE SET SPEED. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND WAS NEGATIVE FOR ANY COMPRESSION OF THE OUTFLOW GRAFT. AN ECHOCARDIOGRAM SHOWED ADEQUATE LEFT VENTRICULAR LEAD UNLOADING. THE PATIENT APPEARED DRY, SO FLUIDS WERE ADMINISTERED AND MEDICATION WAS OPTIMIZED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177063 ↗
• MalfunctionJun 4, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT ROUTINE REVIEW OF LOG FILES DATA REVEALED A VENTRICULAR ASSIST DEVICE (VAD) MOTOR START EVENT WITH STARTING PAR AMETERS OUTSIDE OF THE TYPICAL RANGE. 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 22143909 ↗
• MalfunctionMay 28, 2025Disconnection; Increase in Suction; Power Problem; Disconnection; Increase in Suction; Power Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED MULTIPLE SUCTION ALARMS AND THE CONTROLLER EXHIBITED A POWER LOSS EVENT DUE TO A DOUBLE DISCONNECT OF THE POWER SOURCES. THE REASON FOR THE DOUBLE DISCONNECT OF POWER SOURCES WITH THE CONTROLLER WAS UNKNOWN. THE VAD AND THE 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 22098806 ↗
• InjuryMay 27, 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 EXTENSIVE DRAINAGE AT THE DRIVELINE EXIT SITE (DLES), WHICH WAS ASSOCIATED WITH AN EXTERNAL DRIVELINE (DL) INFECTION. THE PATIENT PRESENTED WITH AN INTERNATIONAL NORMALIZED RATIO OF 8.0 ON ADMISSION, ELEVATED LACTIC ACID DEHYDROGENASE, AND SLIGHTLY ELEVATED HEMOLYSIS LABS. IT WAS NOTED THAT PATIENT CALLED IN OVER THE WEEKEND COMPLAINING OF DRAINAGE FROM THE DLES AND HAD PREVIOUSLY CALLED WEEKS BEFORE AND WAS ADVISED TO COME IN FOR EVALUATION, BUT THE PATIENT REFUSED. THE PATIENT HAD BEEN ON ANTIBIOTICS PRIOR TO ADMISSION AND WAS STARTED ON INTRAVENOUS VANCOMYCIN UPON ADMISSION TO A LOCAL HOSPITAL. NO DEVICE MALFUNCTION WAS REPORTED. THE PATIENT WAS ALIVE WITH NO INJURY. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Hemolysis; Lactate Dehydrogenase Increased; Medical device site infection; Unspecified Infection

  MAUDE report 22091403 ↗
• InjuryMay 13, 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 WITH A HISTORY OF CARDIOMYOPATHY EXPERIENCED A STERNAL INFECTION LEADING TO POSITIVE BLOOD CULTURES, INDICATING BACTEREMIA. THE INFECTION WAS IDENTIFIED AS BACTERIAL. THE PATIENT WAS HOSPITALIZED AND UNDERWENT DIAGNOSTIC TESTS, INCLUDING CULTURES, WHITE BLOOD CELL COUNT, AND A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH CONFIRMED POSITIVE BLOOD CULTURES. MEDICAL INTERVENTIONS INCLUDED THE ADMINISTRATION OF ANTIBIOTICS, SURGICAL DEBRIDEMENT, INTRAVENOUS ANTIBIOTICS, AND STERNAL DEBRIDEMENT. THE VAD REMAINS IN USE.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 22012110 ↗
• MalfunctionMay 9, 2025Power Problem; Pumping Problem; Power Problem; Pumping Problem

  IT WAS REPORTED THAT REVIEW OF LOG FILE DATA IT REVEALED MOTOR START EVENTS WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE AND LOW FLOW ALARMS. ALSO, ON LOG FILE REVIEW THERE WAS AN UNEXPECTED 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 21995205 ↗
• MalfunctionMay 8, 2025Disconnection; Electrical /Electronic Property Problem; Loose or Intermittent Connection; Pumping Stopped; Material Integrity Problem; Disconnection; Electrical /Electronic Property Problem; Loose or Intermittent Connection; Pumping Stopped; Material Integrity Problem

  IT WAS REPORTED THAT WHILE A PATIENT WITH A HISTORY OF CARDIOMYOPATHY WAS ON A HOSPITAL UNIT, AN ELECTRICAL FAULT ALARM WAS TRIGGERED ON THE VENTRICULAR ASSIST DEVICE (VAD). UPON INVESTIGATION, IT WAS FOUND THAT THE DRIVELINE WAS PARTIALLY DISCONNECTED FROM THE CONTROLLER. THE NURSE RECONNECTED THE DRIVELINE, RESOLVING THE ALARM. LOGFILES DATA INDICATED TWO DISCONNECT ALARMS DURING THIS PERIOD. AN ENGINEER INSPECTED THE DRIVELINE AND FOUND IT SECURE BUT NOTED THAT THE DRIVELINE COVER WAS LOOSE AND SUSPECTED IT MAY HAVE CONTRIBUTED TO THE DISCONNECTION. THE PATIENT REFUSED THE REMOVAL OF THE DRIVELINE COVER DESPITE RECOMMENDATIONS. THE SITE WILL CONTINUE TO DISCUSS OPTIONS WITH THE PATIENT. ADDITIONALLY, A VAD STOP ALARM WAS NOTED. THE VAD, DRIVELINE COVER, 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 21986167 ↗
• MalfunctionMay 5, 2025Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING A ROUTINE LOGFILE REVIEW THE VENTRICULAR ASSIST DEVICE (VAD) REVEALED MULTIPLE MOTOR START EVENTS WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE. THE REPORT WAS SENT TO AND DISCUSSED WITH THE SITE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE VAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963371 ↗
• InjuryMar 27, 2025Battery Problem; Pumping Problem; Battery Problem; Pumping Problem

  IT WAS REPORTED THAT A PATIENT WITH A VENTRICULAR ASSIST DEVICE (VAD) EXPERIENCED HIGH WATT LOW FLOW ALARMS, INITIAL CHEST PAIN, AND HYPERTENSION WITH MEAN ARTERIAL PRESSURE (MAP) IN THE 100¿S BUT NOW CONTROLLED. THE PATIENT HAD NOT TAKEN ANTICOAGULANT MEDICATION, SPECIFICALLY COUMADIN, FOR THREE WEEKS DUE TO PSYCHOSOCIAL REASONS AND WAS FOUND TO HAVE SUBTHERAPEUTIC ANTICOAGULATION WITH AN INTERNATIONAL NORMALISED RATIO OF 1.1 UPON ADMISSION. LOG FILES SHOWED AN INCREASE IN POWER/FLOWS INDICATING THROMBUS. THERE WERE NO CHANGES IN THE URINE COLOR YET, BUT THE LACTATE DEHYDROGENASE (LDH) WAS SIGNIFICANTLY ELEVATED. THE PATIENT WAS STARTED ON HEPARIN GTT AS A MEDICAL INTERVENTION. ADDITIONALLY, A CONTROLLER FAULT ALARM OCCURRED DUE TO INTERNAL BATTERY DEPLETION. THE ALARM WAS PERMANENTLY SILENCED, AND NO PLANS FOR A CONTROLLER EXCHANGE HAD BEEN DECIDED AT THIS TIME, UNTIL THE PATIENT CAN BE SEEN BY THE TEAM TO DECIDE THE PLAN OF CARE. IT WAS ALSO REPORTED THAT THE PATIENT WILL MOST LIKELY BE STARTED ON TISSUE PLASMINOGEN ACTIVATOR (TPA) AND HAS WORSENING HEMOLYSIS LABS, BUT A STABLE INTERNATIONAL NORMALIZED RATIO (INR). THE VAD AND CONTROLLER REMAIN IN USE.

  Patient problems: Chest Pain; High Blood Pressure/ Hypertension; Lactate Dehydrogenase Increased; Thrombosis/Thrombus

  MAUDE report 21712654 ↗

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-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-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-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-2188-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1103
• Z-2194-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Implant Kit, REF 1104JP

…and 39 more.