EXCOR® P50P-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04260090040010), received between May 10, 2018 and Feb 9, 2026 — classified as 2 deaths, 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Output Problem” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• DeathFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT THE PATIENT PRESENTED ON (B)(6) 2026 WITH AN ACUTE CHANGE TO NEUROLOGIC EXAM WITH BILATERAL FIXED AND DILATED PUPILS WITH NPI IS 0. TWO HEAD CT WERE PERFORMED SHOWING DIFFUSE LOSS OF GRAY-WHITE MATTER DIFFERENTIATION THROUGH THE BILATERAL CEREBRAL AND CEREBELLAR HEMISPHERES, SLIGHTLY MORE CONSPICUOUS COMPARED TO PRIOR EXAM. REDEMONSTRATION OF DIFFUSE EFFACEMENT OF THE EXTRA-AXIAL SPACES AND BASAL CISTERNS. NEW MILD CEREBELLAR TONSILLAR HERNIATION. THE VENTRICLES ARE SLIT LIKE, SLIGHTLY DECREASED COMPARED TO PRIOR STUDY. THERE IS NO SIGNIFICANT MIDLINE SHIFT. THERE IS NO MASS OR INTRACRANIAL HEMORRHAGE. THE OSSEOUS STRUCTURES APPEAR NORMAL. SCATTERED PARANASAL SINUS OPACIFICATION PREDOMINANTLY IN THE SPHENOID AND ETHMOID SINUSES. OPACIFICATION OF BILATERAL MASTOID AIR CELLS AND MIDDLE EAR CLEFT, LEFT GREATER THAN RIGHT. THE PATIENT CONTINUED TO BE MONITORED, AND THE PATIENT WAS NORMOTHERMIC, NORMOTENSIVE, WITHOUT PARALYSIS/SEDATION AND WITHOUT SIGNIFICANT METABOLIC DERANGEMENTS AT THAT TIME. ON (B)(6) 2026 THE PATIENT WAS WITHDRAWN FROM SUPPORT AND EXPIRED DUE TO POOR OUTCOME PROGNOSIS. THE PATIENT W

  Patient problems: Brain Injury

  MAUDE report 24299758 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2026-01-12 TO REPORT THAT THE PATIENT PRESENTED ON (B)(6) 2026 WITH AN ACUTE CHANGE TO NEUROLOGIC EXAM WITH BILATERAL FIXED AND DILATED PUPILS WITH NPI IS 0. TWO HEAD CT WERE PERFORMED SHOWING DIFFUSE LOSS OF GRAY-WHITE MATTER DIFFERENTIATION THROUGH THE BILATERAL CEREBRAL AND CEREBELLAR HEMISPHERES, SLIGHTLY MORE CONSPICUOUS COMPARED TO PRIOR EXAM. REDEMONSTRATION OF DIFFUSE EFFACEMENT OF THE EXTRA-AXIAL SPACES AND BASAL CISTERNS. NEW MILD CEREBELLAR TONSILLAR HERNIATION. THE VENTRICLES ARE SLIT LIKE, SLIGHTLY DECREASED COMPARED TO PRIOR STUDY. THERE IS NO SIGNIFICANT MIDLINE SHIFT. THERE IS NO MASS OR INTRACRANIAL HEMORRHAGE. THE OSSEOUS STRUCTURES APPEAR NORMAL. SCATTERED PARANASAL SINUS OPACIFICATION PREDOMINANTLY IN THE SPHENOID AND ETHMOID SINUSES. OPACIFICATION OF BILATERAL MASTOID AIR CELLS AND MIDDLE EAR CLEFT, LEFT GREATER THAN RIGHT. THE PATIENT CONTINUED TO BE MONITORED, AND THE PATIENT WAS NORMOTHERMIC, NORMOTENSIVE, WITHOUT PARALYSIS/SEDATION AND WITHOUT SIGNIFICANT METABOLIC DERANGEMENTS AT THAT TIME. ON (B)(6) 2026 THE PATIENT WAS WITHDRAWN FROM SUPPORT AND EXPIRED DUE TO POOR OUTCOME PROGNOSIS. THE PATIENT WA

  Patient problems: Brain Injury

  MAUDE report 24296471 ↗
• 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 CLINIC ON 2025-07-03 THAT A PATIENT WAS PRESENTED WITH A HEADACHE, AND A CT SCAN WAS PERFORMED. A SMALL HEMORRHAGIC STROKE WAS IDENTIFIED ON (B)(6) 2025. ANTICOAGULATION WAS STOPPED BUT OVER THE NEXT DAYS THE BLEEDING INCREASED, AND THE PATIENT WAS DECLARED BRAIN DEAD AND DIED ON (B)(6) 2025 DUE TO MASSIVE CEREBRAL HEMORRHAGE. THE PATIENT WAS BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM. NO DEPOSITS IN THE EXCOR BLOOD PUMP WERE RECORDED.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 22569673 ↗
• InjuryJul 1, 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 ON 2025-06-10 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM EXPERIENCED HEMOLYSIS ON (B)(6) 2025. THE PATIENT HAD A DIALYSIS CATHETER PLACED ON (B)(6) 2025 WITH CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) STARTED THE SAME DAY. THE PATIENT'S LDH AND PFHGB LEVELS INCREASED SINCE PLACEMENT OF THE DIALYSIS CATHETER AND INITIATION OF CRRT. LDH INCREASED FROM 730U/L ON (B)(6) 2025 TO 5823 U/L ON (B)(6) 2025. PFHGB LEVELS INCREASED FROM 7 MG/DL ON (B)(6) 2025 TO 265 MG/DL ON (B)(6) 2025. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION. THE BLOOD PUMP CONTINUES TO REMAIN ON THE PATIENT.

  Patient problems: Hemolysis

  MAUDE report 22378211 ↗
• InjuryJul 1, 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 ON (B)(6) 2025 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM EXPERIENCED HEMOLYSIS ON (B)(6) 2025. THE PATIENT HAD A DIALYSIS CATHETER PLACED ON (B)(6) 2025 WITH CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) STARTED THE SAME DAY. THE PATIENT'S LDH AND PFHGB LEVELS INCREASED SINCE PLACEMENT OF THE DIALYSIS CATHETER AND INITIATION OF CRRT. LDH INCREASED FROM 730U/L ON (B)(6) 2025 TO 5823 U/L ON (B)(6) 2025. PFHGB LEVELS INCREASED FROM 7 MG/DL ON (B)(6) 2025 TO 265 MG/DL ON (B)(6) 2025. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION. THE BLOOD PUMP CONTINUES TO REMAIN ON THE PATIENT.

  Patient problems: Hemolysis

  MAUDE report 22377979 ↗
• InjuryJan 2, 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 CLINIC THAT DURING THE NIGHT OF (B)(6)2024 THE PATIENT SUPPORTED WITH AN EXCOR PEDIATRIC SYSTEM IN BI-VAD CONFIGURATION, SHOWED VERY SHORT SPEECH WEAKNESS. A HEAD CT SCAN WAS PERFORMED AND SHOWED HEMORRHAGIC STROKE. THE ANTICOAGULATION HAS BEEN STOPPED UPON THE RECOMMENDATION OF A NEURO CONSULTANT AT CLINIC. MOREOVER, ON (B)(6)2024, THROMBUS WAS SEEN IN THE OUTFLOW VALVE AREA OF THE LVAD, AND A DECISION WAS MADE TO CHANGE THE LVAD PUMP. HOWEVER, THE THROMBUS WAS NO LONGER PRESENT AT THE TIME THE SURGEON ARRIVED. THEREFORE, THE PUMP WAS NOT CHANGED. DURING THE EVENING OF (B)(6)2024., A SMALL FIBRIN/THROMBUS LAYER WAS OBSERVED IN THE LVAD, AND IT WAS DECIDED TO MONITOR THE PUMP. THE PUMP WAS LATER CHANGED ON (B)(6)2024 AFTER HEMORRHAGIC STROKE AND THE PATIENT REMAINED ASYMPTOMATIC UNTIL THE MORNING. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED WITH FULL FILL AND EJECTION. THE PATIENT SHOWED NO SIGNS OF INFECTION.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 21057090 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART INC. CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC THAT THE PATIENT, WHO HAD ONLY CANNULAS IMPLANTED, HAD PRESUMED ANOXIC BRAIN INJURY. WHEN TRANSITIONING FROM CENTRIMAG TO BERLIN HEART EXCOR ACTIVE SYSTEM, EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM RVAD, SN (B)(6) AND LVAD SN (B)(6) WERE INADVERTENTLY CONNECTED INCORRECTLY (RA TO AO AND LV TO PA). THE TEAM RAPIDLY IDENTIFIED IT, BUT THE PATIENT DECOMPENSATED, REQUIRING EPI, DEFIBRILLATION, AND INTUBATION TO PROTECT THE AIRWAY. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS DID FUNCTION AS INTENDED WITH IMPROPER CANNULA CONNECTIONS TO THE BERLIN HEART PUMP.

  Patient problems: Hypoxia

  MAUDE report 20046301 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART INC. CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC THAT THE PATIENT, WHO HAD ONLY CANNULAS IMPLANTED, HAD PRESUMED ANOXIC BRAIN INJURY. WHEN TRANSITIONING FROM CENTRIMAG TO BERLIN HEART EXCOR ACTIVE SYSTEM, EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM RVAD, SN (B)(6) AND LVAD SN (B)(6) WERE INADVERTENTLY CONNECTED INCORRECTLY (RA TO AO AND LV TO PA). THE TEAM RAPIDLY IDENTIFIED IT, BUT THE PATIENT DECOMPENSATED, REQUIRING EPI, DEFIBRILLATION, AND INTUBATION TO PROTECT THE AIRWAY. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS DID FUNCTION AS INTENDED WITH IMPROPER CANNULA CONNECTIONS TO THE BERLIN HEART PUMP.

  Patient problems: Hypoxia

  MAUDE report 20043713 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART INC. CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC THAT THE PATIENT, WHO HAD ONLY CANNULAS IMPLANTED, HAD PRESUMED ANOXIC BRAIN INJURY. WHEN TRANSITIONING FROM CENTRIMAG TO BERLIN HEART EXCOR ACTIVE SYSTEM, EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM; LVAD, SN (B)(6) AND RVAD SN (B)(6) WERE INADVERTENTLY CONNECTED INCORRECTLY (RA TO AO AND LV TO PA). THE TEAM RAPIDLY IDENTIFIED IT, BUT THE PATIENT DECOMPENSATED, REQUIRING EPI, DEFIBRILLATION, AND INTUBATION TO PROTECT THE AIRWAY. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS DID FUNCTION AS INTENDED WITH IMPROPER CANNULA CONNECTIONS TO THE BERLIN HEART PUMP.

  Patient problems: Hypoxia

  MAUDE report 20043391 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART INC. CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC THAT THE PATIENT, WHO HAD ONLY CANNULAS IMPLANTED, HAD PRESUMED ANOXIC BRAIN INJURY. WHEN TRANSITIONING FROM CENTRIMAG TO BERLIN HEART EXCOR ACTIVE SYSTEM, EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM; LVAD, SN (B)(6) AND RVAD SN (B)(6) WERE INADVERTENTLY CONNECTED INCORRECTLY (RA TO AO AND LV TO PA). THE TEAM RAPIDLY IDENTIFIED IT, BUT THE PATIENT DECOMPENSATED, REQUIRING EPI, DEFIBRILLATION, AND INTUBATION TO PROTECT THE AIRWAY. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS DID FUNCTION AS INTENDED WITH IMPROPER CANNULA CONNECTIONS TO THE BERLIN HEART PUMP.

  Patient problems: Hypoxia

  MAUDE report 20042025 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT ON (B)(6) 2024, THE PATIENT DEMONSTRATED A LOSS OF THEIR COUGH AND GAG REFLEXES, AS WELL AS DIFFUSE WEAKNESS THAT WAS MILDLY ASYMMETRIC. A HEAD CT WAS OBTAINED CONFIRMING A SMALL MCA INFARCT. ADDITIONALLY, THE PATIENT DEVELOPED A GI BLEED ON THE SAME DAY, SO ALL ANTICOAGULATION WAS STOPPED. NEURO WAS CONSULTED, AND NO OTHER INTERVENTIONS WERE RECOMMENDED. THE SITE IS CONTINUING CLOSE MONITORING FOR ANY NEUROLOGICAL CHANGES. THE BERLIN HEART EXCOR BLOOD PUMP FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING, AND EMPTYING THROUGHOUT THE EVENT. TWO SMALL PUNCTATE DEPOSITS WERE NOTED ON THE LVAD INFLOW AT THE TIME OF THE EVENT AND WERE STABLE THROUGHOUT. A PUMP CHANGE WAS NOT PERFORMED.

  Patient problems: Ischemia Stroke

  MAUDE report 18609188 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT ON (B)(6) 2024 THE PATIENT DEMONSTRATED A LOSS OF THEIR COUGH AND GAG REFLEXES, AS WELL AS DIFFUSE WEAKNESS THAT WAS MILDLY ASYMMETRIC. A HEAD CT WAS OBTAINED CONFIRMING A SMALL MCA INFARCT. ADDITIONALLY, THE PATIENT DEVELOPED A GI BLEED ON THE SAME DAY, SO ALL ANTICOAGULATION WAS STOPPED. NEURO WAS CONSULTED, AND NO OTHER INTERVENTIONS WERE RECOMMENDED. THE SITE IS CONTINUING CLOSE MONITORING FOR ANY NEUROLOGICAL CHANGES. THE BERLIN HEART EXCOR BLOOD PUMP FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING, AND EMPTYING THROUGHOUT THE EVENT. TWO SMALL PUNCTATE DEPOSITS WERE NOTED ON THE LVAD INFLOW AT THE TIME OF THE EVENT AND WERE STABLE THROUGHOUT. A PUMP CHANGE WAS NOT PERFORMED.

  Patient problems: Ischemia Stroke

  MAUDE report 18609141 ↗
• MalfunctionJan 22, 2024Output Problem; Output Problem

  THE SITE CONTACTED BERLIN HEART INC. TO REPORT THAT DURING THE IMPLANT PROCEDURE, THE PUMP (SN (B)(6) WAS PLACED ON THE PATIENT BUT DURING THE STEPPING PROCESS, THE PUMP WOULD NOT ACHIEVE THE END DIASTOLIC (FILLING) POSITION. EVEN AFTER SETTING CHANGES WERE MADE, AND HAND PUMPING WAS ATTEMPTED, THE PUMP STILL DID NOT REACH THE END DIASTOLIC POSITION. CLINICAL AFFAIRS ADVISED TO PERFORM A PUMP CHANGE AT THIS TIME. AFTER CHANGING THE PUMP, THE NEW PUMP WAS ABLE TO ACHIEVE FULL FILL/EJECT AND FUNCTION AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18558827 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE WERE INFORMED BY THE CLINIC THAT A PATIENT HAD AN ADVERSE EVENT ON (B)(6) 2021 THE CLINIC REPORTED THAT THE PATIENT SUFFERED FROM AN ISCHEMIC CVA. THE PATIENT HAD AN INFARCTION IN THE MEDIAL CEREBRAL ARTERY 4 WEEKS AGO. WITHOUT ANY SYMPTOMS OR PHYSIOLOGICAL DYSFUNCTION. ON (B)(6) 2021 THE PATIENT SHOWED APOPLEXY AND WAS BLEEDING FROM THE MEDIAL CEREBRAL ARTERY. VENOUS BLEEDING WAS STOPPED AND CT CONFIRMED. THE PATIENT WAS RESPONSIVE, ORIENTED AND AWAKE. THERE WERE DEPOSITS SEEN IN THE BLOOD PUMP AT THE TIME OF THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 12029027 ↗
• MalfunctionApr 23, 2020Break; Break

  WE WERE INFORMED BY OUR DISTRIBUTOR THAT THE LEFT EXCOR BLOOD PUMP OF A PATIENT IMPLANTED IN THE BVAD CONFIGURATION WAS EXCHANGED DUE TO A THROMBUS. AFTER THE EXCHANGE, THE BLOOD PUMP WAS CUT OPEN BY THE SITE AND BLOOD AGGLOMERATES WERE DISCOVERED BETWEEN THE BLOOD-SIDE LAYER AND THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE. A MEMBRANE DEFECT WAS SUSPECTED. THE CLINIC HAD PROVIDED BERLIN HEART (B)(4) WITH PICTURES OF THE BLOOD PUMP AFTER IT WAS CUT OPEN. THE AFFECTED EXCOR BLOOD PUMP SUPPORTED THE PATIENT AS INTENDED UNTIL IT WAS REPLACED ON (B)(6) 2020. THE AFFECTED EXCOR BLOOD PUMP WAS REPLACED BY TRAINED SPECIALISTS IN THE CLINIC. THE EXCHANGE OF THE BLOOD PUMP WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991178 ↗
• MalfunctionJan 17, 2020Output Problem; Output Problem

  BERLIN HEART (B)(4) WERE INFORMED BY THE CLINIC ABOUT A SUSPECTED MEMBRANE DEFECT OF THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN BVAD CONFIGURATION. THE AFFECTED BLOOD PUMP WAS EXCHANGED BY TRAINED PERSONNEL AT THE CLINIC WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9603844 ↗
• MalfunctionMay 24, 2019Particulates; Particulates

  BERLIN HEART (B)(4) CONTACTED BY THE CLINIC TO REPORT TINY BUMPS NOTED ON THE AIR-SIDE MEMBRANE OF BOTH THE EXCOR BLOOD PUMPS OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE CLINIC THEN PROVIDED BERLIN HEART (B)(4) PERSONNEL VIDEO MATERIAL OF THE AFFECTED BLOOD PUMPS AT THE TIME OF THE INCIDENT. UPON EVALUATION, AN EXCHANGE OF THE AFFECTED BLOOD PUMPS WAS RECOMMENDED. TRAINED PERSONNEL AT THE CLINIC EXCHANGED THE BLOOD PUMP THAT IS THE TOPIC OF THIS REPORT, S/N (B)(4), ON (B)(6) 2019 WITHOUT INCIDENCE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641481 ↗
• MalfunctionMay 24, 2019Particulates; Particulates

  BERLIN HEART (B)(4) CONTACTED BY THE CLINIC TO REPORT TINY BUMPS NOTED ON THE AIR-SIDE MEMBRANE OF BOTH THE EXCOR BLOOD PUMPS OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE CLINIC THEN PROVIDED BERLIN HEART (B)(4) PERSONNEL VIDEO MATERIAL OF THE AFFECTED BLOOD PUMPS AT THE TIME OF THE INCIDENT. UPON EVALUATION, AN EXCHANGE OF THE AFFECTED BLOOD PUMPS WAS RECOMMENDED. TRAINED PERSONNEL AT THE CLINIC EXCHANGED THE BLOOD PUMP THAT IS THE TOPIC OF THIS REPORT, S/N (B)(4), ON (B)(6) 2019 WITHOUT INCIDENCE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641479 ↗
• MalfunctionMay 10, 2018Output Problem; Output Problem

  WE WERE INFORMED BY THE CLINIC THAT LOW FLOW ALARMS ACCOMPANIED BY REDUCED PUMP EJECTION WAS NOTED IN THE RIGHT EXCOR BLOOD PUMP OF AN EXCOR MOBILE PATIENT SUPPORTED IN THE BVAD CONFIGURATION. AN EXCHANGE OF THE DRIVING UNIT DID NOT IMPROVE THE SITUATION. THE CLINIC PROVIDED VIDEOS OF THE INCIDENT. UPON REVIEW OF THE VIDEO MATERIAL, BERLIN HEART PERSONNEL RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP DUE TO A REDUCED PUMP FUNCTION. THE BLOOD PUMP WAS EXCHANGED BY TRAINED PERSONNEL AT THE CLINIC. THE REPLACEMENT OF THE BLOOD PUMP WAS WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502696 ↗

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