THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP 103695Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 00813024010616), received between Nov 6, 2015 and May 12, 2026 — classified as 61 deaths, 47 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (31 reports).

1 FDA recall record name this device's identifier, 1 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 19, 2024Class IOpen, Classified

   Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

   Z-1300-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• DeathMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO ADVANCED HEART FAILURE ON (B)(6) 2026. WHETHER THE OUTCOME WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25156414 ↗
• DeathJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE PATIENT TRANSITIONED TO COMFORT MEASURES ONLY WITH A BOWEL OBSTRUCTION AND WAS NOT A SURGICAL CANDIDATE. THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATORS STATED THAT THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED. THE DEVICE WAS NOT EXPLANTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24164338 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL'S EMERGENCY DEPARTMENT FOR A ONE-DAY HISTORY OF INCREASED SHORTNESS OF BREATH, PRODUCTIVE COUGH, MALAISE, AND CHILLS. THE PATIENT WAS TRANSFERRED AND ADMITTED TO THE HEART FAILURE SERVICE FOR FURTHER WORKUPS. ALTHOUGH NO ALARMS WERE REPORTED OR SEEN IN THE INTERROGATION, THE PATIENT PRESENTED WITH ACUTELY MORE PULSATILITY INDEX (PI) EVENTS IN THE LAST 24 HOURS OF ADMISSION WITHOUT A KNOWN CAUSE. AN ECHOCARDIOGRAM AND HEMOLYSIS LABORATORY STUDIES WERE COMPLETED. THE LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG CAPTURED ROUTINE EVENTS. THERE WAS AN INCREASE OF PI EVENTS NOTICED BUT THE VENTRICULAR ASSIST DEVICE (VAD) AND THE PERIPHERAL EQUIPMENT WAS FUNCTIONING AS INTENDED. ECHO RESULTS SHOWED DEPRESSED LEFT VENTRICULAR FUNCTION, NO AORTIC INSUFFICIENCY, MILD MITRAL REGURGITATION, AND MODERATE TRICUSPID REGURGITATION. LACTATE DEHYDROGENASE (LDH) WAS STABLE AT 277 COMPARED TO 287 TWO WEEKS PRIOR. NO CLINICAL FINDINGS OF HEMOLYSIS WERE PRESENT. THE PATIENT'S SYMPTOMS WERE DETERMINED TO BE CAUSED BY MILD HYPERVOLEMIA AND RESPIRATORY VIRAL RHINOVIRUS. THE PATIENT WAS DISCHARGED HOME ON A SLIGHTLY HIGHER DIURETIC DOSE

  Patient problems: Dyspnea; Hypovolemia; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24027475 ↗
• DeathDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER COMMUNICATED THAT THE STROKE WAS HEMORRHAGIC. THE PATIENT HAD CATASTROPHIC BRAIN BLEEDING FROM BRAIN METASTASIS. THEY HAD COMMON NEUROLOGIC SYMPTOMS INCLUDING IMPAIRED SPEECH AND HEMIPLEGIA. THE DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED AND WAS STATED TO HAVE OPERATED AS EXPECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemorrhagic Stroke; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Speech Disorder; Stroke/CVA

  MAUDE report 23682305 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS READMITTED FOR BLOODY STOOL. BLEEDING WAS CONFIRMED HOWEVER TWO SUPERFICIAL ESOPHAGEAL ULCERS HAD NO EVIDENCE OF RECENT BLEEDING AND FIVE ANGIOECTASIAS WERE NOTED WITH BLEEDING THAT WERE FOUND IN THE GASTRIC ANTRUM. THE BLEEDING RESOLVED. HEMOSTASIS WAS ACHIEVED USING ARGON PLASMA.

  Patient problems: Gastrointestinal Hemorrhage; Melena

  MAUDE report 23393546 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS ADMITTED ON (B)(6) 2025 FOR GASTROINTESTINAL BLEEDING (GIB) AND ESOPHAGOGASTRODUODENOSCOPY (EGD). 7 CLIPS WERE REQUIRED. THE BLEEDING WAS RESOLVED THE PATIENT WAS DISCHARGED ON (B)(6) 2025.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23360836 ↗
• DeathOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY SECONDARY TO MULTISYSTEM ORGAN FAILURE, AFTER THEY TRANSITIONED TO HOSPICE. NO AUTOPSY WAS PERFORMED, AND THE DEVICE WAS NOT EXPLANTED.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 23316477 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH RISING LACTATE DEHYDROGENASE (LDH) OF 1,200. NO ALARMS WERE NOTED. LOG FILES CAPTURED ROUTINE EVENTS THROUGHOUT THE LOG. AT THIS TIME, THERE WERE NO PLANS FOR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OR ECHOCARDIOGRAM (ECHO) AS THE PATIENT WAS CLINICALLY STABLE AND HAD A HISTORY OF FLUCTUATING LDH LEVELS. THE CAUSE OF ELEVATED LDH WAS DETERMINED TO BE MULTIFACTORIAL, CHRONIC MACROANGIOPATHIC HEMOLYSIS DUE TO THE LEFT VENTRICULAR ASSIST DEVICE (LVAD), HEPATIC CONGESTION FROM HEART FAILURE EXACERBATION, AND ONGOING CHRONIC INFECTION. DELAFLOXACIN WAS GIVEN FOR CHRONIC INFECTION. LDH CONTINUED TO TREND. THE PATIENT WAS NOT HAVING ANY OTHER SYMPTOMS AT THIS TIME. ADDITIONAL LOG FILES SHOWED NO UNUSUAL EVENTS RECORDED. THERE WERE NO CHANGES TO THE INFECTION INCLUDING SOURCE, CULTURE, OR SYMPTOMS/TREATMENT SINCE (B)(6) 2017, WHICH WAS THE DATE OF ONSET INFECTION.

  Patient problems: Bacterial Infection; Hemolysis; Lactate Dehydrogenase Increased; Skin Infection

  MAUDE report 22906879 ↗
• InjuryJul 17, 2025Mechanical Problem; Decreased Pump Speed; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Decreased Pump Speed; Adverse Event Without Identified Device or Use Problem

  IT WAS ADDITIONALLY REPORTED THAT HEMOLYSIS WAS NOT CONFIRMED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED, WHICH SHOWED NO CHANGE FROM THE PATIENTS PREVIOUS TEES. THE HEMOLYSIS LATER RESOLVED.

  Patient problems: Hemolysis; Lactate Dehydrogenase Increased

  MAUDE report 22538894 ↗
• MalfunctionApr 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE CUSTOMER HAD SOME DIFFICULTY SECURING THE LOCKING MECHANISM ON THE NEW SYSTEM CONTROLLER WITH THE RUBBER PIECE STILL ON THE CONNECTOR, BUT THE PUMP WAS RUNNING. THE CUSTOMER WAS ABLE TO CUT OFF THE RUBBER PIECE, FULLY ENGAGED THE DRIVELINE INTO THE NEW SYSTEM CONTROLLER AND ENGAGE THE LOCKING MECHANISM WITHOUT INCIDENT. THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE BY CUTTING AWAY THE RUBBER SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21850255 ↗
• DeathApr 2, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PREVIOUSLY UNDER MFR # 2916596-2025-00764 THAT WERE CONCERNS FOR NEEDING A TOUGHER DRIVELINE. IT WAS NOTED THAT THERE WERE DEATHS IN THE HEARTMATE II TRIAL FROM CAR DOOR TRANSECTIONS. THE HEARTMATE II TRIAL WAS A BRIDGE TO TRANSPLANT (BTT) TRIAL. THE PATIENT'S HEARTWARE WAS "WEAR" TESTED BY SLAMMING DOORS DUE TO THIS EVENT. THEY WERE NOTED TO BE MUCH TOUGHER COMPARED TO HEARTMATE DRIVELINES. HEARTMATE 3 WAS NOTED TO BE BETTER THAN HEARTMATE II WHICH WERE DELICATE AND FLIMSY.

  Patient problems: Insufficient Information

  MAUDE report 21752962 ↗
• InjuryFeb 12, 2025Mechanical Problem; Decreased Pump Speed; Pumping Stopped; Mechanical Problem; Decreased Pump Speed; Pumping Stopped

  IT WAS ADDITIONALLY REPORTED THAT THE SYSTEM CONTROLLER WAS EXCHANGED AS PART OF EQUIPMENT REPAIR.

  Patient problems: Dyspnea

  MAUDE report 21366787 ↗
• DeathJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE ISSUE OCCURRED MORE THAN ONCE (MFR # 2916596-2025-02228).

  Patient problems: Insufficient Information

  MAUDE report 21285313 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR GASTROINTESTINAL (GI) BLEEDING ON (B)(6) 2023. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED WITHOUT EVIDENCE OF ACTIVE BLEEDING AND NO CLEAR SOURCE OF MELENA. THE PATIENT WAS ON WARFARIN FOR THE LEFT VENTRICULAR ASSIST DEVICE (LVAD). THEY HAD BLOOD IN THEIR ESOPHAGUS CONSISTENT WITH EPISTAXIS, AND A FRIABLE HYPEREMIC DUODENUM. TWO POLYP BIOPSIES WERE TAKEN. IT WAS DECIDED TO DISCONTINUE ALL ANTICOAGULATION GIVEN THE RISK OF GI BLEED REOCCURRENCE. THE PATIENTS RESULT FOR HELICOBACTER PYLORI (H. PYLORI) WAS NEGATIVE. THEY RECEIVED 3 UNITS PACKED RED BLOOD CELL (PRBC). THEY WERE STARTED ON AN INTRAVENOUS (IV) PROTON PUMP INHIBITOR (PPI) WITH CONVERSION TO ORAL PANTOPRAZOLE 40MG BI-DAILY FOR 8 WEEKS. THE PATIENT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Epistaxis; Gastrointestinal Hemorrhage; Hyperemia

  MAUDE report 21234727 ↗
• DeathJan 23, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC AND NOTED TO HAVE SOME ISOLATED EVENTS OF ELEVATED FLOWS AND POWER. PATIENT HAD NOT NOTICED ANY CHANGES TO THEIR PARAMETERS AND HAD NOT HAD ANY ALARMS OR DARK/DISCOLORED URINE. LABS DRAWN IN THE CLINIC WERE STILL PENDING. THE PATIENT DID NOT TAKE COUMADIN DUE TO PREVIOUS GASTROINTESTINAL BLEEDS. THE PATIENT DID TAKE ACETYLSALICYLIC ACID 81 MILLIGRAMS DAILY. LOG FILES WERE SENT FOR REVIEW, AND THEY CAPTURED SEVERAL ELEVATED POWERS AND FLOWS OVER THE COURSE OF THE LOG FILE WITH POWER NOTED AS HIGH AS 9.1W. THESE WERE ALL ASSOCIATED WITH PULSATILITY INDEX (PI) EVENTS. THE ELEVATED PUMP POWERS WERE ALL TRANSIENT AND NOT SUSTAINED. THE CAUSE OF THE ELEVATED PUMP POWERS WAS NOT IDENTIFIED AT THE TIME. THE PATIENT DID NOT HAVE ANY ASSOCIATED SYMPTOMS WITH THE ELEVATED FLOWS AND POWER. AS TREATMENT THE PATIENT WAS RE-STARTED ON COUMADIN WITH AN INTERNATIONAL NORMALIZED RATIO (INR) GOAL RANGE OF 1.8-2.3. AS ON (B)(6) 2025, THE PATIENT HAD NOT NOTICED ANY MORE FLOW OR POWER ELEVATIONS. SUPPLEMENTAL INFORMATION PROVIDED NEW LOG FILES, AND LAB WORK WAS PENDING. THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2025 FOR SURVEILLANCE OF PREVIOUSLY REPOR

  Patient problems: Heart Failure/Congestive Heart Failure; Hemodynamic instability; Lactate Dehydrogenase Increased; Liver Damage/Dysfunction; Thrombosis/Thrombus; Valvular Insufficiency/ Regurgitation

  MAUDE report 21225932 ↗
• DeathJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY AND THE CAUSE WAS UNKNOWN. IT WAS STATED THAT THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED. THE CUSTOMER STATED THAT NO FURTHER INFORMATION WOULD BE PROVIDED. AN AUTOPSY WAS NOT PERFORMED AND WOULD NOT BE PROVIDED. THE PUMP WAS NOT EXPLANTED AND WOULD NOT BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 21087994 ↗
• DeathJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PASSED AWAY AND THE CAUSE OF DEATH IS UNKNOWN. THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED. THE CUSTOMER ALSO STATED THAT NO FURTHER INFORMATION WAS AVAILABLE. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21085102 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INCREASING POWER REQUIREMENTS THOUGHT TO BE RELATED TO SEPSIS VASODILATION DUE TO NEW ONSET DRIVELINE INFECTION.

  Patient problems: Sepsis; Skin Infection; Vasodilatation

  MAUDE report 20741583 ↗
• InjuryOct 15, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT LOG FILES WERE SENT FOR EVALUATION DUE TO CONCERN FOR PUMP THROMBUS. THE DATA THAT WAS REVIEWED DID NOT CONTAIN ATTRIBUTES WHICH WOULD LEAD TO SUSPECT THE PRESENCE OF THROMBUS WITHIN THE MOTOR CHAMBER; HOWEVER, THAT DOES NOT MEAN THAT THROMBUS WAS NOT PRESENT IN THE CIRCULATORY LOOP. IT WAS RECOMMENDED TO LOOK AT OTHER CLINICAL INDICATIONS THAT MAY CONFIRM THE PRESENCE OF THROMBUS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20451900 ↗
• MalfunctionSep 18, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR A PATIENT WITH EXTENSIVE DAMAGE AND WEAR ON THEIR DRIVELINE, WHICH HAD OCCURRED OVER MANY YEARS. THE PATIENT DENIED ANY ALARMS. DESPITE THE DAMAGE OBSERVED TO THE DRIVELINE, THE LOG FILE DATA INDICATED THAT THE INTERNAL CONDUCTORS WERE STILL INTACT. AN EXTERNAL DRIVELINE REVISION WAS NOT REQUIRED AT THIS TIME. THERE WERE (2) NO EXTERNAL POWER EVENTS RECORDED WHILE CONNECTED TO MOBILE POWER UNIT (MPU). THIS WAS LIKELY CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THE EMERGENCY BACKUP BATTERY WAS USED TO SUPPORT THE SYSTEM DURING THESE EVENTS. MOTOR FUNCTION WAS NOT AFFECTED BY THIS EVENT. REGARDING THE MPU, THE POWER CORD WAS OF THE LOCKING TYPE. THE PATIENT STATED THEY DID NOT RECALL THESE SPECIFIC POWER EVENTS, BUT THEY LIVED IN A SEMI-RURAL AREA AND HAD FREQUENT POWER OUTAGES FROM CLAY ELECTRIC. THE SYSTEM CONTROLLER HAD NEVER HAD AN ALARM THAT THEY COULD RECALL WITHOUT THERE BEING AN EXPLAINABLE POWER OUTAGE. LAYERS OF RESCUE TAPE WAS APPLIED JUST BEHIND THE CLAM SHELL REPAIR AND TO GRADUALLY REDUCE THE LAYERS AS THE WRAPPING CONTINUED TOWARD THE EXIT SITE TO REPRODUCE A BEND RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251478 ↗
• DeathSep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿PRELIMINARY REPORT OF EXTRACORPOREAL BLOOD PURIFICATION THERAPY IN PATIENTS RECEIVING LVAD: CYTOSORB OR JAFRON HA330¿ IDENTIFYING THAT HEARTMATE 3 (HM3) IS ASSOCIATED ELEVATED PROINFLAMMATORY CYTOKINES, KIDNEY INJURY, POSTOPERATIVE BLEEDING, AND DEATH DUE MULTIORGAN FAILURE. THIS IS A RETROSPECTIVE STUDY THAT REVIEWED PROSPECTIVELY COLLECTED DATA FROM 15 PATIENTS WHO UNDERWENT LEFT VENTRICULAT ASSIST DEVICE (LVAD) HM 3 IMPLANTATION AT A SINGLE TERTIARY CARE CENTER BETWEEN JANUARY 2021 AND MARCH 2022. INTRAOPERATIVELY, PATIENTS WERE SINGLE RANDOMIZED 1:1:1 TO THREE GROUPS: GROUP 1, PATIENTS WHO RECEIVED CYTOSORB THERAPY (N = 5; INSTALLED IN THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT); GROUP 2, PATIENTS WHO RECEIVED JAFRON HA330 (N = 5; INSTALLED IN THE CPB CIRCUIT); AND CONTROL GROUP 3, PATIENTS WHO DID NOT RECEIVE FILTER (N = 50) USUAL CARE, NEITHER CYTOSORB NOR JAFRON DURING CPB. DATA WERE OBTAINED FROM A PROSPECTIVELY COLLECTED INSTITUTIONAL LVAD DATABASE THAT INCLUDED DETAILED INFORMATION ON PATIENT DEMOGRAPHICS, BASELINE CLINICAL CHARACTERISTICS, LABORATORY AND HEMODYNAMIC PARAMETERS, INTRAOPERATIVE VARIABLES, AND POSTOPERATIVE

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 20193864 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿PRELIMINARY REPORT OF EXTRACORPOREAL BLOOD PURIFICATION THERAPY IN PATIENTS RECEIVING LVAD: CYTOSORB OR JAFRON HA330¿ IDENTIFYING THAT HEARTMATE 3 (HM3) IS ASSOCIATED ELEVATED PROINFLAMMATORY CYTOKINES, KIDNEY INJURY, POSTOPERATIVE BLEEDING, AND DEATH DUE MULTIORGAN FAILURE. THIS IS A RETROSPECTIVE STUDY THAT REVIEWED PROSPECTIVELY COLLECTED DATA FROM 15 PATIENTS WHO UNDERWENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) HM 3 IMPLANTATION AT A SINGLE TERTIARY CARE CENTER BETWEEN JANUARY 2021 AND MARCH 2022. INTRAOPERATIVELY, PATIENTS WERE SINGLE RANDOMIZED 1:1:1 TO THREE GROUPS: GROUP 1, PATIENTS WHO RECEIVED CYTOSORB THERAPY (N = 5; INSTALLED IN THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT); GROUP 2, PATIENTS WHO RECEIVED JAFRON HA330 (N = 5; INSTALLED IN THE CPB CIRCUIT); AND CONTROL GROUP 3, PATIENTS WHO DID NOT RECEIVE FILTER (N = 50) USUAL CARE, NEITHER CYTOSORB NOR JAFRON DURING CPB. DATA WERE OBTAINED FROM A PROSPECTIVELY COLLECTED INSTITUTIONAL LVAD DATABASE THAT INCLUDED DETAILED INFORMATION ON PATIENT DEMOGRAPHICS, BASELINE CLINICAL CHARACTERISTICS, LABORATORY AND HEMODYNAMIC PARAMETERS, INTRAOPERATIVE VARIABLES, AND POSTOPERATIVE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 20193852 ↗
• DeathJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO RIGHT HEART FAILURE. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. AN AUTOPSY WAS NOT PERFORMED AND THE DEVICE WAS NOT EXPLANTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19705586 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ADDITIONALLY REPORTED THAT PROTEUS MIRABILIS WAS IDENTIFIED AT THE TIME OF ONSET, AND ORAL ANTIBIOTICS WERE ADMINISTERED.

  Patient problems: Drug Resistant Bacterial Infection; Skin Infection

  MAUDE report 19635418 ↗
• MalfunctionJun 25, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT CENTER NORMALLY FENESTRATED THE OUTFLOW GRAFT THE DURING PREPARATION OF THE OUTFLOW GRAFT. WHEN THEY ATTEMPTED TO MAKE THE HOLES IN THE BEND RELIEF, THE OUTFLOW GRAFT SPLIT. THE OUTFLOW GRAFT WAS DISCARDED, AND A NEW ONE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607776 ↗