Thoratec® HeartMate 3™ 105581USRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00813024013266), received between Sep 6, 2018 and May 26, 2026 — classified as 3 deaths, 13 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 reports).

2 FDA recall records 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-1301-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

2. Mar 30, 2019Class IITerminated

   Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

   Z-2349-2019 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• DeathMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESEARCH ARTICLE, ¿GUIDELINE DIRECTED MEDICAL THERAPY ASSOCIATIONS WITH LATE RIGHT HEART FAILURE IN PATIENTS ON HEARTMATE 3 SUPPORT.¿ A RETROSPECTIVE, SINGLE CENTER STUDY EVALUATING ASSOCIATIONS BETWEEN GUIDELINE DIRECTED MEDICAL THERAPY (GDMT) AND LATE RIGHT HEART FAILURE (L RHF) IN PATIENTS SUPPORTED WITH THE HEARTMATE 3 (HM3) LVAD. THIS STUDY EVALUATED LATE RIGHT HEART FAILURE (L RHF) IN 314 PATIENTS SUPPORTED WITH THE HEARTMATE 3 LVAD AND ASSESSED ASSOCIATIONS WITH GUIDELINE DIRECTED MEDICAL THERAPY. L RHF OCCURRED IN 18.8% OF PATIENTS AND WAS ASSOCIATED WITH LOWER INCIDENCE OF L-RHF IN HM3 SUPPORTED PATIENTS; USE OF BETA BLOCKERS, RAAS INHIBITORS, AND SGLT2 INHIBITORS WAS PROTECTIVE, WHILE NEED FOR AMIODARONE, DIURETICS, HYDRALAZINE, OR PDE 5 INHIBITORS WAS ASSOCIATED WITH HIGHER RISK. FIVE-YEAR SURVIVAL WAS REDUCED FOR L-RHF PATIENT VS NO RHF PATIENTS, 51.9% VS 78.5%, P< 0.01.

  Patient problems: Insufficient Information

  MAUDE report 25280156 ↗
• DeathFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EFFECT OF LEFT VENTRICULAR (LV) SIZE ON CLINICAL OUTCOMES FOLLOWING A DURABLE LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION WITH HEARTMATE 3 (HM3) WAS UNCLEAR. THE CLINICAL OUTCOMES OF PATIENTS AFTER HM3 AS A FUNCTION OF LV SIZE IN A MULTICENTER INTERNATIONAL REGISTRY WAS INVESTIGATED. A RETROSPECTIVE PROPENSITY SCORE-ADJUSTED ANALYSIS OF ADULT PATIENTS FROM THE EUROMACS REGISTRY WHO UNDERWENT A HM3 IMPLANTATION BETWEEN AUG2014 AND FEB2023 WAS PERFORMED. PATIENTS WITH PREOPERATIVE LV END DIASTOLIC DIAMETER (LVEDD) ASSESSMENTS AND WITHOUT PREVIOUS OR CONCOMITANT CARDIAC SURGERIES AND TEMPORARY MECHANICAL CIRCULATORY SUPPORT WERE INCLUDED. PATIENTS WERE DIVIDED INTO THREE GROUPS ACCORDING TO THEIR LVEDD: =65; 65-80 AND =80 MM. RESULTS CONTAINED 860 PATIENTS IDENTIFIED; WITH A MEAN AGE 54.4±12.4 YRS, MEAN BSA 2.0±0.23 M2, AND MEAN BMI 27.3±5.0 KG/M2, 87.9% WERE MALE, 40% HAD ISCHEMIC CARDIOMYOPATHY, THE GROUP WITH A LVEDD =65 MM WAS SIGNIFICANTLY OLDER (56.1±11.0 YRS VS.53.8±13.0 YRS VS. 53.0±12.3 YRS, P=0.015), MORE LIKELY FEMALE (17.9% VS. 11.6% VS. 4.9%, P<0.001) AND HAD SMALLER BSA (1.95±2.03 VS.2.01±0.22 VS. 2.08±0.22, P<0.01) AND BMI (26.6±4.8 VS. 27.4±5.1 VS.

  Patient problems: Insufficient Information

  MAUDE report 21298152 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿IMPELLA AS BRIDGE TO DURABLE LEFT VENTRICULAR ASSIST DEVICE IN ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK PATIENTS?¿ IDENTIFYING THAT HEARTMATE 3 (HM3) MAY BE RELATED TO BLEEDING POST-LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT THAT REQUIRED SURGICAL REVISION. FROM 2013 TO 2023, 21 PATIENTS WITH CARDIOGENIC SHOCK AFTER ACUTE MYOCARDIAL INFARCTION WERE SUPPORTED WITH AN IMPELLA DEVICE AS A BRIDGE TO DURABLE LVAD IMPLANTATION. ALL PATIENTS (100%) WERE SUCCESSFULLY BRIDGED TO DURABLE LVAD IMPLANTATION. SEVEN PATIENTS (33%) WERE IMPLANTED WITH THE HEARTWARE LVAD (HVAD; MEDTRONIC INC.), AND 14 (67%) WITH THE HEARTMATE 3. AFTER LVAD IMPLANT, 5 PATIENTS (24%) REQUIRED SURGICAL REVISION FOR BLEEDING WITHIN 48 HOURS, AND 8 PATIENTS (38%) REQUIRED SURGICAL REVISION FOR BLEEDING WITHIN 7 DAYS POST-LVAD IMPLANT. THIS DATA FIRST SHOWED THAT BRIDGING ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI-CS) PATIENTS TO DURABLE LVAD IMPLANTATION WITH AN IMPELLA DEVICE WAS FEASIBLE WITHIN FEW WEEKS FROM THE INDEX EVENT IN ALL PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21148381 ↗
• MalfunctionJan 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 6% OF HF/LVAD-RELATED READMISSIONS WERE FOR DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129841 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEARTMATE3 (HM3) WAS ASSOCIATED WITH BLEEDING, INFECTION, HEART FAILURE (HF) EXACERBATION, NEUROLOGICAL DYSFUNCTION, CARDIAC ARRHYTHMIA, DEVICE MALFUNCTION, ANTICOAGULATION ADJUSTMENT, PRE-SYNCOPE AND SYNCOPE, HYPOTENSION AND HYPOVOLEMIA, ELECTROLYTE ABNORMALITIES, RENAL FAILURE, RESPIRATORY DISTRESS/FAILURE, AND CHEST PAIN. THE AIM OF THIS STUDY WAS TO IDENTIFY RISK FACTORS ASSOCIATED WITH HOSPITAL READMISSIONS AMONG PATIENTS WITH CONTINUOUS FLOW -LEFT VENTRICULAR ASSIST DEVICES (CF-LVADS). THIS RETROSPECTIVE STUDY EVALUATED PATIENTS IMPLANTED WITH A CF-LVAD BETWEEN FEBRUARY 2011 AND MARCH 2021 USING PROSPECTIVELY MAINTAINED INSTITUTIONAL DATABASES. HOSPITAL READMISSIONS WITHIN THREE YEARS POST-LVAD IMPLANTATION WERE DICHOTOMIZED INTO HEART FAILURE (HF)/LVAD-RELATED OR NON-HF/LVAD-RELATED READMISSIONS. A TOTAL OF 31% PF PATIENT WERE IMPLANTED WITH HM3. PATIENTS WITH AN HF/LVAD-RELATED READMISSION WERE MORE COMMONLY SUPPORTED WITH THE HVAD MEDTRONIC, MINNEAPOLIS, MN, USA) (75.4% VERSUS 57.6%, P=0.014) AS OPPOSED TO THE HM3 LVAD (ABBOTT LABORATORIES, CHICAGO, IL, USA). THIS RESULTED IN A FINAL COHORT OF 204 PATIENTS, AND 586 READMISSIONS WERE OBSERVED DURING

  Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Multiple Organ Dysfunction Syndrome; Renal Failure; Skin Infection; Syncope/Fainting

  MAUDE report 21129702 ↗
• MalfunctionDec 5, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING PUMP PREP, IT WAS NOTICED THAT THE OUTFLOW GRAFT BEND RELIEF HAD LIFTING OF THE MATERIAL AT THE DISTAL END OF THE GRAFT. BEND RELIEF WAS NOT USED AS PROTOCOL FOR THIS CENTER, BUT THE SITE WANTED TO REPORT WHAT WAS SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858389 ↗
• InjurySep 16, 2024Device Difficult to Setup or Prepare; No Apparent Adverse Event; Device Difficult to Setup or Prepare; No Apparent Adverse Event

  IT WAS ADDITIONALLY REPORTED THROUGH VOLUNTARY MEDWATCH REPORT MW5161965 THAT THE PATIENT HAD A HISTORY OF DILATED NONISCHEMIC CARDIOMYOPATHY COMPLICATED BY SEVERE LEFT VENTRICULAR SYSTOLIC DYSFUNCTION, MILD RIGHT VENTRICULAR SYSTOLIC DYSFUNCTION, SEVERE MITRAL REGURGITATION, AND PAROXYSMAL ATRIAL FIBRILLATION IN SECONDARY TO ALCOHOL, COCAINE, AND METHAMPHETAMINES USE. THE STATUS POST LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND TRICUSPID VALVE REPAIR WITH A 28 MM MC3 ANNULOPLASTY RING 2021. SINCE 2023 THEY HAVE HAD HOSPITALIZATIONS FOR METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) BACTEREMIA. THE PATIENT HAD SUBARACHNOID HEMORRHAGE AT THE TIME THOUGHT TO BE SECONDARY TO MYCOTIC ANEURYSM. IN 2023 THEY WERE HOSPITALIZED AGAIN FOR PERSISTENT MSSA BACTEREMIA, HAD THEIR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) EXPLANTED AND COMPLETED 6 WEEKS OF INTRAVENOUS (IV) ANTIBIOTICS. AFTER THEY WERE TRANSITIONED TO CEFADROXIL INDEFINITELY FOR SUPPRESSION OF INFECTION. THEY THEN PRESENTED WITH A FEVER OF 103.2 WITH SYMPTOMS OF NAUSEA, VOMITING, AND CHILLS. THE PATIENT HAD STOPPED TAKING CEFADROXIL IN 2024 DUE TO NO REFILLS AS THEY HADN'T BEEN SEEN IN THE CLINIC. THEY WERE TREATED WITH IV

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Shock; Stroke/CVA

  MAUDE report 20226710 ↗
• DeathJun 26, 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 SEPTIC SHOCK. THE OUTCOME WAS NOT CONSIDERED DEVICE OR THERAPY RELATED. THE DEVICE OPERATED AS EXPECTED.

  Patient problems: Septic Shock

  MAUDE report 19616101 ↗
• MalfunctionMay 14, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PUMP PREPARATION THERE WAS A DEFECT VISUALIZED BY THE OR NURSE SCRUB TECHNICIAN ON THE OUTFLOW GRAFT WITHIN THE PURPLE HOUSING. SCRATCHES WERE SEEN AND NOTED BY PHOTOGRAPH ON THE PURPLE HOUSING INSIDE OF THE THREADED OUTFLOW GRAFT ATTACHMENT TO THE PUMP. THE IMPLANT KIT (B)(6) WAS DETERMINED TO BE DEFECTIVE AND WAS SENT BACK FOR EVALUATION. THE SYSTEM CONTROLLER THAT CAME WITH THE NEW IMPLANT KIT WAS BEING RETURNED WITH THE DEFECTIVE IMPLANT KIT. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315666 ↗
• MalfunctionMar 29, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING PUMP PREPARATION, THE OUTFLOW GRAFT HAD 3 THREADS AT THE DISTAL END. THE DISTAL END OF THE OUTFLOW GRAFT WAS SNIPPED OFF AND PUMP PREPARATION CONTINUED. THE OUTFLOW GRAFT TIP WAS PASSED OFF THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006356 ↗
• MalfunctionFeb 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON MANIPULATED THE OUTFLOW GRAFT BEND RELIEF WITH SCALPEL AND 5.0 AORTIC PUNCH DUE TO CONCERNS FOR EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO). AFTER CREATING ONE OF THE HOLES USING THE 5.0 PUNCH, THE BEND RELIEF IN THE AREA OF THE PUNCH FRACTURED. THE SURGEON WAS UNSURE IF THEY ACCIDENTLY HIT ONE OF THE PLASTIC RINGS. THE OUTFLOW GRAFT WAS REPLACED WITH THE OUTFLOW GRAFT FROM THE BACKUP KIT. THE SURGEON REQUESTED ANALYSIS TO CONFIRM THE CAUSE OF THE FRACTURED BEND RELIEF. THE FRACTURED BEND RELIEF AND OUTFLOW GRAFT WERE TO BE RETURNED TO ABBOTT. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18690786 ↗
• MalfunctionOct 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT PUMP PREPARATION, THE OPERATING ROOM NURSE OBSERVED OUTFLOW GRAFT 8928557 FROM IMPLANT KIT: (B)(6) HAD A VISIBLE FOLD AT THE END OF THE BEND RELIEF. THE SURGEON WAS CONCERNED THIS WOULD IMPINGE ON THE FUNCTION OF THE OUTFLOW GRAFT SO THEY USED OUTFLOW GRAFT 8408593 FROM IMPLANT KIT: (B)(6) TO REPLACE OUTFLOW GRAFT 8928557. IT WAS OBSERVED THAT OUTFLOW GRAFT 8408593 ALSO HAD A VERY SLIGHT FOLD AT THE END OF THE BEND RELIEF, HOWEVER IT WAS STILL IMPLANTED WITH PUMP: (B)(6). THERE WERE NO PATIENT CONSEQUENCES. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4) - OUTFLOW GRAFT 8928557.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013902 ↗
• MalfunctionOct 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT PUMP PREPARATION, THE OPERATING ROOM NURSE OBSERVED OUTFLOW GRAFT 8928557 FROM IMPLANT KIT (B)(6) HAD A VISIBLE FOLD AT THE END OF THE BEND RELIEF. THE SURGEON WAS CONCERNED THIS WOULD IMPINGE ON THE FUNCTION OF THE OUTFLOW GRAFT SO THEY USED OUTFLOW GRAFT 8408593 FROM IMPLANT KIT (B)(6) TO REPLACE OUTFLOW GRAFT 8928557. IT WAS OBSERVED THAT OUTFLOW GRAFT 8408593 ALSO HAD A VERY SLIGHT FOLD AT THE END OF THE BEND RELIEF, HOWEVER IT WAS STILL IMPLANTED WITH PUMP (B)(6). THERE WERE NO PATIENT CONSEQUENCES. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-07287 - OUTFLOW GRAFT 8408593.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013816 ↗
• MalfunctionAug 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PUMP PREP AFTER THE OUTFLOW GRAFT WAS ATTACHED, IT WAS NOTICED THAT THERE WAS LEAKING AT THE POINT OF CONNECTION WHERE THE DACRON MET THE METAL. THE OUTFLOW GRAFT WAS REMOVED AND REPLACED. THE LEAKING OCCURRED AGAIN. ANOTHER OUTFLOW GRAFT WAS OPENED AND ATTACHED WHICH LEAKED AS WELL. A THIRD OUTFLOW GRAFT WAS OPENED AND THIS TIME IT DID NOT LEAK. RELATED MFR # 2916596-2023-06113.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654858 ↗
• MalfunctionAug 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PUMP PREP AFTER THE OUTFLOW GRAFT WAS ATTACHED, IT WAS NOTICED THAT THERE WAS LEAKING AT THE POINT OF CONNECTION WHERE THE DACRON MET THE METAL. THE OUTFLOW GRAFT WAS REMOVED AND REPLACED. THE LEAKING OCCURRED AGAIN. ANOTHER OUTFLOW GRAFT WAS OPENED AND ATTACHED WHICH LEAKED AS WELL. A THIRD OUTFLOW GRAFT WAS OPENED AND THIS TIME IT DID NOT LEAK. RELATED MFR # 2916596-2023-06114.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654848 ↗
• MalfunctionMay 9, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE METAL RING ON THE OUTFLOW GRAFT BEND RELIEF LACERATED THE OUTFLOW GRAFT WHILE THE SURGEON ATTEMPTED TO CONNECT THE TWO. THE SURGEON REPAIRED THE OUTFLOW GRAFT WITH SUTURE AND CHOSE NOT TO USE THE BEND RELIEF. IT WAS LATER REPORTED THAT THE PATIENT WAS ALIVE AND PROGRESSING TO INPATIENT REHAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897453 ↗
• MalfunctionApr 14, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SURGEON HAD PUNCH A HOLE IN THE BEND RELIEF DURING PUMP PREPARATION AND THE BEND RELIEF CAME APART DURING THE PREP PHASE BEFORE IT WAS PLACED IN THE PATIENT. THE SURGEON WANTED TO CUT A SMALL SLIT AND USE A PUNCH BETWEEN THE RIBS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746972 ↗
• MalfunctionApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THERE WAS A SHORT DELAY WHILE A NEW OUTFLOW GRAFT WAS RETRIEVED BUT NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712988 ↗
• MalfunctionDec 28, 2022Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE ISSUE DID NOT CAUSE A SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061529 ↗
• InjuryDec 19, 2022Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE HEARTMATE 3 IMPLANT PROCEDURE, THE PATIENT UNDERWENT REHABILITATION. LOW FLOW ALARMS WERE NOTED IN THE LOG FILES ON (B)(6) 2022. A COMPUTED TOMOGRAPHY (CT) IMAGE REVEALED INCREASED FLUID COLLECTION AROUND THE OUTFLOW GRAFT AND A CONTRAST ENHANCED CT IMAGE SUSPECTED A FALSE BUMP. THE PATIENT HAD SEROMA AROUND THE OUTFLOW GRAFT ON CT. A THORACOTOMY PROCEDURE WAS PERFORMED AND A HEMATOMA, WHICH WAS FOUND AT THE ANASTOMOTIC REGION OF THE OUTFLOW GRAFT OF THE HEARTMATE 3 AND THE NIPRO EXTERNAL VENTRICULAR ASSIST DEVICE, WAS REMOVED ALONG WITH THE SEROMA. AFTER THE SURGERY, THE DECREASED PUMP FLOW RECOVERED.

  Patient problems: Hematoma; Seroma

  MAUDE report 16007139 ↗
• MalfunctionDec 9, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHILE THE OUTFLOW GRAFT WAS BEING PREPPED FOR IMPLANT, FRAYING WAS NOTICED AT THE CONNECTOR. A NEW OUTFLOW GRAFT WAS USED FOR IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15953293 ↗
• MalfunctionOct 25, 2022Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING PUMP PREPARATION, THE OUTFLOW GRAFT WAS CUT WHEN THE HEMOSTAT WAS PLACED. A NEW OUTFLOW GRAFT WAS USED FOR THE PROCEDURE. THE OUTFLOW GRAFT AND BEND RELIEF WERE TO BE SENT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668445 ↗
• MalfunctionMay 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN OUTFLOW GRAFT MALFUNCTION. THE GRAFT WAS EXCHANGED AND THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488607 ↗
• InjuryFeb 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION, BLEEDING WAS NOTED AT THE JUNCTION OF THE OUTFLOW GRAFT AND THE METAL CONNECTION BEFORE THE DEVICE WAS TURNED ON. THE SURGEON PLACED A SUTURE ON THE OUTFLOW GRAFT WHERE THE GRAFT CONNECTS TO THE METAL CONNECTION, BUT THE BLEEDING CONTINUED. THE ORIGINAL OUTFLOW GRAFT FROM THE IMPLANT KIT WAS CUT NEAR THE AORTIC ANASTOMOSIS AND A STAND-ALONE OUTFLOW GRAFT WAS ANASTOMOSED TO THE CUT END OF THE ORIGINAL GRAFT. NO BLEEDING WAS NOTED FROM THE NEW OUTFLOW GRAFT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13537372 ↗
• MalfunctionFeb 9, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING PUMP PREPARATION THE IMPLANTING SURGEON NOTICED A SMALL FLECK IN THE OUTFLOW GRAFT. THE SITE DECIDED NOT TO USE IT AS IT WAS REPORTED AS ¿OUT OF BOX FAILURE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497814 ↗