EXCOR® P15P-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 04260090040157), received between Sep 24, 2015 and Sep 29, 2026 — classified as 2 deaths, 129 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Output Problem” (83 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (H100004, P160035); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 18, 2018Terminated

   There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.

   Z-1618-2023 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 236 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026 the site contacted to Berlin Heart Clinical Affairs to report that a patient, who was supported with an EXCOR pediatric VAD system, suffered several strokes with subsequent hemorrhagic conversion. On (b)(6) 2026 an arterial non-CNS thromboembolism was identified in spleen, kidney, liver and mesenteric ileus. Small fibrin deposits were noted in the pump during other neurological events.The support was withdrawn and transitioned to palliative care on (b)(6) 2026.

  Patient problems: Thromboembolism

  MAUDE report 50938067 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2026-04-03 TO REPORT THAT A PATIENT EXPERIENCED STROKE RELATED TO CLINICAL FOCAL SEIZURE WITH LEFT ARM AND FACIAL JERKING ON (B)(6) 2026. A CT SCAN PERFORMED ON THE DATE OF THE EVET REVEALED RIGHT PARIETAL MCA TERRITORY INFARCT IN SETTING OF DECREASED OPACIFICATION OF THE RIGHT POSTERIOR RIGHT M3 AND M4 BRANCHES. THEE RESULT OF THE FOLLOWING SCAN SHOWED AN EVOLVING RIGHT POSTERIOR MCA TERRITORY INFARCT WITH PERSISTENT, THOUGH LESS CONSPICUOUS LOSS OF GREY-WHITE DIFFERENTIATION IN THE POSTERIOR RIGHT, FRONTAL, PARIETAL, AND TEMPORAL LOBES. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION. A SMALL WHITE FIBRIN WAS NOTED AT THE OUTFLOW CONNECTOR AND INFLOW CONNECTOR. THE PATIENT WAS SUCCESSFULLY TRANSPLANTED ON (B)(6) 2026.

  Patient problems: Ischemia Stroke

  MAUDE report 25052271 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS (CA) ON 2026-02-27 TO REPORT THAT A PATIENT BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM EXPERIENCED HEMOLYSIS ON (B)(6) 2026. THE PATIENT WAS PREVIOUSLY BEING SUPPORTED ON VA-ECMO AND THE EXCOR CANNULAS WERE IMPLANTED WITH CENTRIMAG ON (B)(6) 2026. AFTER THE SWITCH FROM THE CENTRIMAG TO EXCOR BLOOD PUMP ON (B)(6) 2026, THE LDH LEVEL INCREASED. THE PREVIOUS LDH HAVE BEEN BELOW 500 U/L AND THE VALUE INCREASED TO OVER 1500 U/L FOR THREE DAYS FROM (B)(6) 2026. THE PATIENT REMAINS STABLE. THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION.

  Patient problems: Hemolysis

  MAUDE report 24698519 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2026-01-19 TO REPORT THAT ON (B)(6) 2026 A PAN-SCAN CT WAS PERFORMED ON THE PATIENT WITH BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, S/N (B)(6), FOLLOWING BLOOD STREAM INFECTION AND AN ISCHEMIC CVA WAS INCIDENTALLY FOUND. THE IMAGING WAS MOST CONSISTENT WITH SUBACUTE RIGHT PCA STROKE, NO MOVEMENT OF VISUALIZED FIBRIN AFTER THE EVENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH ONLY CANNULAS ON (B)(6) 2025 AND IS BEING SUPPORTED WITH THE FULL EXCOR SYSTEM SINCE 2025-12-29. SINCE THAT TIME, THE PATIENT HAS BEEN SUFFERED FROM SEVERAL BACTERIAL AND FUNGAL INFECTIONS. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED MAINTAINING FULL FILL AND EJECT. DEPOSITS WERE NOTED IN THE PUMP BEFORE AND AFTER THE CONFIRMATION OF CVA.

  Patient problems: Brain Injury

  MAUDE report 24306086 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2026-01-19 TO REPORT THAT ON (B)(6) 2026 A PAN-SCAN CT WAS PERFORMED ON THE PATIENT WITH BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, S/N (B)(6), FOLLOWING BLOOD STREAM INFECTION AND AN ISCHEMIC CVA WAS INCIDENTALLY FOUND. THE IMAGING WAS MOST CONSISTENT WITH SUBACUTE RIGHT PCA STROKE, NO MOVEMENT OF VISUALIZED FIBRIN AFTER THE EVENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH ONLY CANNULAS ON (B)(6) 2025 AND IS BEING SUPPORTED WITH THE FULL EXCOR SYSTEM SINCE (B)(6) 2025. SINCE THAT TIME, THE PATIENT HAS BEEN SUFFERED FROM SEVERAL BACTERIAL AND FUNGAL INFECTIONS. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED MAINTAINING FULL FILL AND EJECT. DEPOSITS WERE NOTED IN THE PUMP BEFORE AND AFTER THE CONFIRMATION OF CVA.

  Patient problems: Brain Injury

  MAUDE report 24305092 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2025-11-26 TO REPORT THAT ON (B)(6) 2025, THE PATIENT PRESENTED WITH NEW ONSET GENERALIZED CONVULSIVE SEIZURE, WITH NOTED GAZE UP AND TO THE LEFT. CT WAS OBTAINED ON (B)(6) 2025 AND NOTED INTRACRANIAL HEMORRHAGE (ICH). AFTER CONSULTING WITH NEUROSURGERY, SURGICAL EVACUATION WAS NOT RECOMMENDED. NEUROSURGERY WANTS TO ALLOW THE ICH TO RESORB ON ITS OWN. THE PATIENT WAS LOADED WITH KEPPRA AND CONTINUED, ALL ANTICOAGULATION PLACED ON HOLD (B)(6) 2025 AND RESUMED (B)(6) 2025. SERIAL CTS WERE PERFORMED FROM (B)(6) 2025 TO (B)(6) 2025. THE PATIENT IS BEING SUPPORTED WITH THE EXCOR SYSTEM IN BI-VAD CONFIGURATION. THE EXCOR BLOOD PUMPS MAINTAINED FULL FILLING AND EJECTION. DEPOSITS WERE NOTED IN BOTH PUMPS.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 23849714 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2025-11-26 TO REPORT THAT ON (B)(6) 2025, THE PATIENT PRESENTED WITH NEW ONSET GENERALIZED CONVULSIVE SEIZURE, WITH NOTED GAZE UP AND TO THE LEFT. CT WAS OBTAINED ON (B)(6) 2025 AND NOTED INTRACRANIAL HEMORRHAGE (ICH). AFTER CONSULTING WITH NEUROSURGERY, SURGICAL EVACUATION WAS NOT RECOMMENDED. NEUROSURGERY WANTS TO ALLOW THE ICH TO RESORB ON ITS OWN. THE PATIENT WAS LOADED WITH KEPPRA AND CONTINUED, ALL ANTICOAGULATION PLACED ON HOLD (B)(6) 2025 AND RESUMED (B)(6) 2025. SERIAL CTS WERE PERFORMED FROM (B)(6) 2025 TO (B)(6) 2025. THE PATIENT IS BEING SUPPORTED WITH THE EXCOR SYSTEM IN BI-VAD CONFIGURATION. THE EXCOR BLOOD PUMPS MAINTAINED FULL FILLING AND EJECTION. DEPOSITS WERE NOTED IN BOTH PUMPS.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 23849591 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS (CA) ON 2025-10-09 TO REPORT THAT A PATIENT BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM SUFFERED AN ISCHEMIC STROKE. THE PATIENT WAS NOTED TO HAVE RIGHT-SIDED WEAKNESS AND A FACIAL DROOP ON 2025-10-07. A CT SCAN WAS PERFORMED ON THE EVENT DAY AND REVEALED A LEFT MCA INFARCT. THE CT SCAN SHOWED THAT THERE WAS NEAR TOTAL OCCLUSIVE STENOSIS OF THE LEFT MCA, THE DISTAL MCA BRANCHES ARE OPACIFIED AND THERE ARE NO OTHER FOCAL FILLING DEFECTS. THIS FOCAL SEGMENT CORRELATES TO THE AREA OF HYPERDENSITY ON THE RECENT NON CONTRAST CT HEAD, THEREFORE, IT WAS MOST CONSISTENT WITH ACUTE THROMBUS. ACCORDING TO THE UPDATE ON 2025-10-09, THERE WAS SOME IMPROVEMENT IN MOVEMENT OF THE RIGHT ARM AND LEG, AND THE PATIENT REMAINED SELF-VENTILATING AND NOT TOO IRRITABLE. MULTIPLE SMALL FIBRIN DEPOSITS WERE NOTED IN THE PUMP, HOWEVER, THE CLINIC DECIDED NOT TO CHANGE THE PUMP BEFORE AND AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 23452590 ↗
• MalfunctionOct 17, 2025Output Problem; Output Problem

  BERLIN HEART GMBH CLINICAL AFFAIRS (CA) WAS INFORMED BY THE ITALIAN DISTRIBUTOR ON 2025-03-23 THAT A PUMP CHANGE WAS PERFORMED DUE TO A SUSPICIOUS MEMBRANE ISSUE ON THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM. THE SITE CHANGED THE PUMP WITHOUT COMPLICATIONS AND REPORTED THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT HAD NO NEGATIVE EFFECTS DUE TO THE INCIDENT. THEREFORE, INITIALLY BERLIN HEART HAS DETERMINED THIS EVENT AS NOT REPORTABLE. HOWEVER UPON REVIEWING THE FAILURE INVESTIGATION ON 2025-09-17, THE EVENT WAS DETERMINED AS REPORTABLE DUE TO A CONFIRMED DEFECT IN ONE OF THE LAYERS OF THE TRIPLE LAYER MEMBRANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327065 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON 2025-09-25 TO REPORT THAT ON (B)(6) 2025 THE PATIENT WITH LVAD EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; 9 MM, WAS AWAKE, ALERT, TRACKING TOYS AND FACES AND IN NO APPARENT DISTRESS. THE PATIENT'S LEFT ARM WAS ANTIGRAVITY WITH SPONTANEOUS MOVEMENTS, MORE SO THAN THE LEFT LEG. THE RIGHT ARM, ON EXAMINATION WAS NOTED TO BE PLEGIC WITHOUT ANY SPONTANEOUS MOVEMENT EVEN WHEN STIMULATED WITH NOXIOUS STIMULI. THE RIGHT LEG WAS ALSO NOTED TO BE PARETIC/WEAK WITH MOVEMENTS ONLY IN THE PLANE OF THE BED. AN ELECTROENCEPHALOGRAM (EEG) PERFORMED AT THE TIME OF THE EVENT REVEALED DIFFUSE SLOWING AND FOCAL SLOWING OVER THE RIGHT AND THE LEFT CENTROTEMPORAL REGIONS. NO SEIZURES OR NO EPILEPTIFORM DISCHARGES WERE NOTED. THE EXCOR BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION. DEPOSITS WERE NOTED IN THE PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 23311044 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON 2025-09-25 TO REPORT THAT ON (B)(6) 2025 THE PATIENT WITH LVAD EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, WAS AWAKE, ALERT, TRACKING TOYS AND FACES AND IN NO APPARENT DISTRESS. THE PATIENT'S LEFT ARM WAS ANTIGRAVITY WITH SPONTANEOUS MOVEMENTS, MORE SO THAN THE LEFT LEG. THE RIGHT ARM, ON EXAMINATION WAS NOTED TO BE PLEGIC WITHOUT ANY SPONTANEOUS MOVEMENT EVEN WHEN STIMULATED WITH NOXIOUS STIMULI. THE RIGHT LEG WAS ALSO NOTED TO BE PARETIC/WEAK WITH MOVEMENTS ONLY IN THE PLANE OF THE BED. AN ELECTROENCEPHALOGRAM (EEG) PERFORMED AT THE TIME OF THE EVENT REVEALED DIFFUSE SLOWING AND FOCAL SLOWING OVER THE RIGHT AND THE LEFT CENTROTEMPORAL REGIONS. NO SEIZURES OR NO EPILEPTIFORM DISCHARGES WERE NOTED. THE EXCOR BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION. DEPOSITS WERE NOTED IN THE PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 23310546 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS IN THE WEEKLY UPDATE STATING THAT THE PATIENT, WHO WAS ORIGINALLY SUPPORTED WITH AN EXCOR BLOOD PUMP, WAS TRANSITIONED TO CENTRIMAG ON (B)(6) 2025. THE SITE STATED THAT THE TRANSITION WAS DUE TO THE NEED FOR BETTER HEMODYNAMICS. THE SITE ALSO STATED THAT THE HEMOLYSIS VALUE FOR THE PATIENT INCREASED TO 3927 MG/DL COMPARED TO THE PRE-LDH VALUE OF 1243 MG/DL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION.

  Patient problems: Hemolysis

  MAUDE report 23279004 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS IN THE WEEKLY UPDATE STATING THAT THE PATIENT, WHO WAS ORIGINALLY SUPPORTED WITH AN EXCOR BLOOD PUMP, WAS TRANSITIONED TO CENTRIMAG ON (B)(6) 2025. THE SITE STATED THAT THE TRANSITION WAS DUE TO THE NEED FOR BETTER HEMODYNAMICS. THE SITE ALSO STATED THAT THE HEMOLYSIS VALUE FOR THE PATIENT INCREASED TO 3927 MG/DL COMPARED TO THE PRE-LDH VALUE OF 1243 MG/DL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION.

  Patient problems: Hemolysis

  MAUDE report 23278701 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS (CA) ON 2025-09-01 TO REPORT A NEW EVENT ON A PATIENT WHO EXPERIENCED SUBDURAL HEMATOMA ON (B)(6) 2025. AFTER REDUCING ANTICOAGULATION, THE SIZE OF THE HEMATOMA DECREASED. HOWEVER, THE CT SCAN ON (B)(6) 2025 SHOWED THAT THERE ARE LOW ATTENUATING CHANGES ON THE LEFT SIDE OF BRAIN, INDICATING AN ISCHEMIC CONDITION. THE ISCHEMIC EVENT APPEARED TO HAVE OCCURRED 24 HOURS EARLIER. THE PATIENT WAS BEING SUPPORTED WITH A LVAD EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, SN (B)(6). SMALL FIBRIN DEPOSITS WERE SEEN PRIOR TO THE EVENT. A PUMP CHANGE WAS PERFORMED ON (B)(6) 2025. THERE ARE NO MORE DEPOSITS AND NO DETERIORATION IN NEUROLOGICAL STATUS.

  Patient problems: Ischemia Stroke

  MAUDE report 23099812 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS (CA) ON (B)(6) 2025 TO REPORT THAT THE PATIENT WITH LVAD EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, HAD EXPERIENCED SOME ACTIVITY THAT WAS SUSPICIOUS FOR SEIZURES ON (B)(6) 2025. A HEAD CT REVEALED TWO SUBDURAL HEMATOMAS. THE PATIENT HAD EPISODES WITH HIGHER BLOOD PRESSURE, COINCIDING WITH LOW-FLOW EPISODES. THE EXCOR BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION AT THE TIME OF THE EVENT. SMALL FIBRIN DEPOSITS WERE NOTED IN THE PUMP. ACCORDING TO THE UPDATE, THE PATIENT BECAME STABLE WITHOUT SEIZURES, AND CONTROL CT SHOWED NO PROGRESSION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23097324 ↗
• MalfunctionSep 8, 2025Output Problem; Output Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THEY TRANSITIONED THE PATIENT FROM CONTINUOUS FLOW TO FULL SYSTEM ON THE EXCOR ACTIVE DRIVER, AND THEY WERE EXPERIENCING POOR FILLING, POOR EJECTION AND LOW FLOWS. BHI CA ASSISTED IN TROUBLESHOOTING THE DRIVER SETTINGS AS WELL AS THE PATIENT'S HEMODYNAMICS. INTERMITTENT IMPROVEMENTS IN EJECTION WERE MADE WITH REPOSITIONING AND INCREASED PERCENT SYSTOLE, BUT THE PUMP WOULD NOT FILL, AND THE FLOW REMAINED LOW. BHI CA REQUESTED AN ECHOCARDIOGRAM TO EVALUATE CANNULA PLACEMENT AND DECOMPRESSION OF THE HEART. DESPITE TROUBLESHOOTING EFFORTS OF BHI, THE SITE DECIDED TO PLACE THE PATIENT BACK ON CONTINUOUS FLOW DUE TO LOW FLOWS BEFORE THE ECHO WAS OBTAINED. THE TRANSITION TO CONTINUOUS FLOW WAS UNEVENTFUL, AND THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT. UPON REVIEWING A VIDEO OF THE RINSED BLOOD PUMP PROVIDED BY THE SITE, BHI CA NOTED THAT THERE WAS A BUBBLE IN THE MEMBRANE WHEN VIEWED FROM THE AIR CHAMBER. THE PUMP WAS COLLECTED ON COMPLAINT FOR FURTHER EVALUATION. THE SITE PROVIDED LOG FILES FROM THE EXCOR ACTIVE DRIVER USED FOR THE IMPLANT. THE LOG FILES SHOWED THAT THE DRIVER WORKED AS INTENDED. IT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999255 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON (B)(6) 2025 TO REPORT THAT THE PATIENT WITH LVAD EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, HAD FEVER IN THE SETTING OF A RUPTURED OVARIAN CYST AND LEFT LOWER LOBE PNEUMONIA, INCLUDING DECREASED MOVEMENT IN THE RIGHT SIDE ON (B)(6) 2025. ON THE NEXT DAY, A CT SCAN WAS PERFORMED AND SHOWED AN ACUTE TO SUBACUTE POSTERIOR LEFT MCA TERRITORY INFARCT. THE EXCOR BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION. DEPOSITS WERE NOTED IN THE PUMP BEFORE AND AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 22612882 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON 2025-07-07 TO REPORT THAT THE PATIENT WITH LVAD EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, HAD FEVER IN THE SETTING OF A RUPTURED OVARIAN CYST AND LEFT LOWER LOBE PNEUMONIA, INCLUDING DECREASED MOVEMENT IN THE RIGHT SIDE ON (B)(6) 2025. ON THE NEXT DAY, A CT SCAN WAS PERFORMED AND SHOWED AN ACUTE TO SUBACUTE POSTERIOR LEFT MCA TERRITORY INFARCT. THE EXCOR BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION. DEPOSITS WERE NOTED IN THE PUMP BEFORE AND AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 22612592 ↗
• DeathJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED BY THE POLAND DISTRIBUTOR ON 2025-06-26 THAT A PATIENT SUFFERED A MINOR HEMORRHAGIC STROKE ON (B)(6) 2025, FOLLOWED BY A MASSIVE HEMORRHAGIC STROKE ON (B)(6) 2025, WHICH UNFORTUNATELY RESULTED IN DEATH. THE PATIENT WAS BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION AND NO DEPOSITS IN THE EXCOR BLOOD PUMP OR ANTICOAGULATION PROBLEM WERE REPORTED.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 22569463 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2025-06-02, BERLIN HEART CLINICAL AFFAIRS WAS INFORMED THAT THE PATIENT SEIZURE ON (B)(6) 2025. CT WAS PERFORMED, AND SMALL CLOTS IN THE BRAIN WERE IDENTIFIED. AT THE TIME OF THE EVENT, SMALL FIBRIN WERE NOTED IN THE INFLOW AND OUTFLOW AREA OF THE EXCOR BLOOD PUMP; 15 ML IN/OUT; Ø 9 MM. THE PATIENT WAS ESCALATED TO A CONTINUOUS FLOW DEVICE ON (B)(6) 2025 AND WAS SUCCESSFULLY WEANED AND EXPLANTED FOR RECOVERY ON (B)(6) 2025.

  Patient problems: Transient Ischemic Attack

  MAUDE report 22375503 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON (B)(6) 2025 TO REPORT THAT THE PATIENT SUPPORTED WITH EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM; WAS NOTED TO HAVE LEFT FACIAL DROOPING, LEFT UPPER AND LOWER EXTREMITY WEAKNESS ON (B)(6) 2025. ON THE SAME DAY, A CT SCAN, WITH AND WITHOUT CONTRAST AS WELL AS PERFUSION SCAN WERE PERFORMED, AND THE RESULTS SHOWED NO ACUTE ABNORMALITY. THERE WAS A CHRONIC RIGHT PARIETAL INFARCT. THIS WAS NEW FROM THE PREVIOUS CT, WHICH SHOWED A PERFUSION ABNORMALITY IN THE REGION. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. THE PUMP WAS NOTED TO HAVE DEPOSITS BEFORE AND AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 22176666 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON 2025-05-13 TO REPORT THAT THE PATIENT SUPPORTED WITH EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM; WAS NOTED TO HAVE LEFT FACIAL DROOPING, LEFT UPPER AND LOWER EXTREMITY WEAKNESS ON 2025-05-09. ON THE SAME DAY, A CT SCAN, WITH AND WITHOUT CONTRAST AS WELL AS PERFUSION SCAN WERE PERFORMED, AND THE RESULTS SHOWED NO ACUTE ABNORMALITY. THERE WAS A CHRONIC RIGHT PARIETAL INFARCT. THIS WAS NEW FROM THE PREVIOUS CT, WHICH SHOWED A PERFUSION ABNORMALITY IN THE REGION. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. THE PUMP WAS NOTED TO HAVE DEPOSITS BEFORE AND AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 22176461 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON (B)(6) 2025 REGARDING A PUMP CHANGE. UPON FURTHER CONVERSATION WITH THE SITE AND THE REVIEW OF THE PUMP CHANGE RECORD, IT WAS NOTED THAT THE PATIENT HAD A STROKE. ON (B)(6) 2025 , THE PATIENT HAD BILATERAL LOWER EXTREMITY TWITCHING, RIGHT SIDED WEAKNESS, AND RIGHT SIDED FACIAL DROOPING. THE PATIENT REMAINED ALERT AND RESPONSIVE WITH EQUAL PUPILS, BUT SYMPTOMS PERSISTED. CT SCAN RESULTS SHOWED MULTIFOCAL ACUTE INFARCTS IN THE MIDDLE CEREBRAL ARTERY (MCA). LEFT GREATER THAN THE RIGHT. NO HEMATOMA OR MIDLINE SHIFT. SEVERE STENOSIS VS. OCCLUSION AT THE LEFT MCA TRIFURCATION. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. THE PUMP WAS NOTED TO HAVE FIBRIN ON THE LATERAL CUSP OF THE OUTFLOW VALVE.

  Patient problems: Ischemia Stroke

  MAUDE report 21914292 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON 2025-03-31 REGARDING A PUMP CHANGE. UPON FURTHER CONVERSATION WITH THE SITE AND THE REVIEW OF THE PUMP CHANGE RECORD, IT WAS NOTED THAT THE PATIENT HAD A STROKE. ON (B)(6) 2025, THE PATIENT HAD BILATERAL LOWER EXTREMITY TWITCHING, RIGHT SIDED WEAKNESS, AND RIGHT SIDED FACIAL DROOPING. THE PATIENT REMAINED ALERT AND RESPONSIVE WITH EQUAL PUPILS, BUT SYMPTOMS PERSISTED. CT SCAN RESULTS SHOWED MULTIFOCAL ACUTE INFARCTS IN THE MIDDLE CEREBRAL ARTERY (MCA). LEFT GREATER THAN THE RIGHT. NO HEMATOMA OR MIDLINE SHIFT. SEVERE STENOSIS VS. OCCLUSION AT THE LEFT MCA TRIFURCATION. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. THE PUMP WAS NOTED TO HAVE FIBRIN ON THE LATERAL CUSP OF THE OUTFLOW VALVE.

  Patient problems: Ischemia Stroke

  MAUDE report 21914165 ↗
• MalfunctionMar 21, 2025Gas/Air Leak; Gas/Air Leak

  ON (B)(6) 2025 BERLIN HEART GMBH CLINICAL AFFAIRS (CA) WAS INFORMED BY THE KOREAN DISTRIBUTOR THAT DURING INTERVENTION OF REMOVING FIBRIN IN THE CONNECTOR SET, IT WAS NOTED THAT AN AIR LEAKAGE OCCURRED AT THE AREA OF THE BLOOD PUMP CONNECTOR TO THE DRIVING TUBE. UPON EVALUATION OF THE PICTURES AND VIDEOS PROVIDED, CA RECOMMENDED REPLACING THE BLOOD PUMP AND REQUESTED THAT THE BLOOD PUMP ALONG WITH THE DRIVING TUBE BE RETURNED TO BERLIN HEART FOR INVESTIGATION. THERE WERE NO ABNORMALITIES NOTED IN THE MOVEMENT OF THE BLOOD PUMP AND NO DAMAGE TO THE CONNECTOR WAS OBSERVED. THEREFORE, THE CLINIC DECIDED TO RETAIN THEM AND MONITOR THE PATIENT. AS OF (B)(6) 2025, THE PATIENT REMAINS CLINICALLY STABLE AND NO NEGATIVE EFFECTS WERE NOTED DUE TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667501 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H100004, P160035. One submission often covers many models, so check the product and lot details in each record.

• Z-2320-2026 · Apr 24, 2026 · Open, Classified
  EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01