EXCOR® P25P-001x01Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 04260090040119), received between Oct 15, 2015 and Nov 4, 2025 — classified as 1 death, 36 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Output Problem” (44 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 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 2025-10-21 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM SUFFERED AN ISCHEMIC STROKE. THE PATIENT WAS NOTED TO HAVE SEIZURE ACTIVITY, DECREASED MUSCULAR TONE, NEW LOWER UPPER EXTREMITY (LUE) WEAKNESS AND HYPERREFLEXIA. A CT SCAN WAS PERFORMED ON THE EVENT DAY AND REVEALED A CHRONIC MCA INFARCT IN CORTICAL, PARIETAL AND FRONTAL TERRITORIES. FIBRIN STRANDS WERE NOTED AT THE OUTFLOW VALVE AND THE IN- AND OUTFLOW CONNECTORS OF THE BLOOD PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 23469522 ↗
• InjuryNov 4, 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 (B)(6) 2025 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM SUFFERED AN ISCHEMIC STROKE. THE PATIENT WAS NOTED TO HAVE SEIZURE ACTIVITY, DECREASED MUSCULAR TONE, NEW LOWER UPPER EXTREMITY (LUE) WEAKNESS AND HYPERREFLEXIA. A CT SCAN WAS PERFORMED ON THE EVENT DAY AND REVEALED A CHRONIC MCA INFARCT IN CORTICAL, PARIETAL AND FRONTAL TERRITORIES. FIBRIN STRANDS WERE NOTED AT THE OUTFLOW VALVE AND THE IN- AND OUTFLOW CONNECTORS OF THE BLOOD PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 23469048 ↗
• DeathNov 4, 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 WHO WAS PREVIOUSLY SUPPORTED IN A BVAD CONFIGURATION HAD BEEN ESCALATED ON (B)(6) 2025 TO CONTINUOUS FLOW CIRCUIT ON THE RIGHT SIDE. ON (B)(6) 2025, THE OVERALL CONDITION OF THE PATIENT HAD WORSENED AND THEREFORE THE PATIENT WAS SEDATED AND CHEMICALLY PARALYZED FOR HEMODYNAMIC INSTABILITY. ON (B)(6) 2025, THE TEAM NOTED PUPILLARY CHANGES FOLLOWED BY POSSIBLE SEIZURE ACTIVITY AND POSTURING, PROMPTING A CT SCAN. IMAGING REVEALED EXTENSIVE INTRAVENTRICULAR HEMORRHAGE AND A NEW LARGE RIGHT PARIETAL INTRAPARENCHYMAL HEMORRHAGE. AN EEG PERFORMED FROM (B)(6) 2025 DEMONSTRATED A SEVERELY SUPPRESSED BACKGROUND, CONSISTENT WITH SEVERE DIFFUSE NEURONAL DYSFUNCTION AND ENCEPHALOPATHY. NEUROSURGICAL CONSULTATION DETERMINED THE FINDINGS WERE CATASTROPHIC AND IRREVERSIBLE, AND NO SURGICAL INTERVENTION WAS OFFERED. NEUROLOGY WAS CONSULTED FOR SEIZURE MANAGEMENT AND MEDICAL STABILIZATION. DUE TO POOR NEUROLOGICAL PROGNOSIS, THE PATIENT WAS WITHDRAWN FROM CARE UPON REQUEST BY THE PATIENT'S FAMLIY AND WAS EXPIRED ON (B)(6) 2025.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 23468576 ↗
• InjuryNov 4, 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 WHO WAS PREVIOUSLY SUPPORTED IN A BVAD CONFIGURATION HAD BEEN ESCALATED ON (B)(6) 2025 TO CONTINUOUS FLOW CIRCUIT ON THE RIGHT SIDE. ON (B)(6) 2025, THE OVERALL CONDITION OF THE PATIENT HAD WORSENED AND THEREFORE THE PATIENT WAS SEDATED AND CHEMICALLY PARALYZED FOR HEMODYNAMIC INSTABILITY. ON (B)(6) 2025, THE TEAM NOTED PUPILLARY CHANGES FOLLOWED BY POSSIBLE SEIZURE ACTIVITY AND POSTURING, PROMPTING A CT SCAN. IMAGING REVEALED EXTENSIVE INTRAVENTRICULAR HEMORRHAGE AND A NEW LARGE RIGHT PARIETAL INTRAPARENCHYMAL HEMORRHAGE. AN EEG PERFORMED FROM (B)(6) 2025 DEMONSTRATED A SEVERELY SUPPRESSED BACKGROUND, CONSISTENT WITH SEVERE DIFFUSE NEURONAL DYSFUNCTION AND ENCEPHALOPATHY. NEUROSURGICAL CONSULTATION DETERMINED THE FINDINGS WERE CATASTROPHIC AND IRREVERSIBLE, AND NO SURGICAL INTERVENTION WAS OFFERED. NEUROLOGY WAS CONSULTED FOR SEIZURE MANAGEMENT AND MEDICAL STABILIZATION. DUE TO POOR NEUROLOGICAL PROGNOSIS, THE PATIENT WAS WITHDRAWN FROM CARE UPON REQUEST BY THE PATIENT'S FAMLIY AND WAS EXPIRED ON (B)(6) 2025.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 23468402 ↗
• MalfunctionNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON 2025-08-21 TO REPORT AN ISSUE WITH THE EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM. PER THE SITE, THE PATIENT WAS AMBULATING IN THE ROOM, SAT DOWN AND THE WHITE DRIVING TUBE CONNECTOR IN THE PUMP PARTIALLY PULLED OUT OF THE PUMP. THE WHITE DRIVING TUBE CONNECTOR WAS REINSERTED, AND THE PUMP CONTINUED TO FUNCTION WITH FULL FILL AND EJECT. THE SITE WAS INFORMED THAT AN EMERGENT PUMP CHANGE WAS REQUIRED DUE TO THE POTENTIAL FOR THE WHITE DRIVING TUBE CONNECTOR TO BE PULLED OUT AGAIN. PER THE SITE, ONCE THE DRIVING TUBE WAS REINSERTED, THE BERLIN EXCOR PUMP FUNCTIONED AS INTENDED, MAINTAINING FULL FILL AND EJECTION. THE PATIENT TOLERATED THE PUMP CHANGE. WITHOUT COMPLICATIONS OR UNTOWARD EFFECTS. DURING THE UPDATE FROM THE SITE ON 2025-08-28, BHI CA WAS INFORMED THE DETAILED SITUATION OF THE EVENT. THE EVENT OCCURRED WHILE THE PATIENT WAS OUTSIDE IN THE COURTYARD AREA, SITTING ON A BLANKET FOR DINNER. WHEN THE PATIENT WAS SITTING DOWN, THE PATIENT PULLED ON THE DRIVING TUBE AND HELD UP THE END WHERE IT CONNECTS TO THE PUMP, WITH THE WHITE CONNECTOR ATTACHED AND ASKED, "IS THIS SUPPOSED TO BE LIKE THIS?". THE NURSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465467 ↗
• MalfunctionJul 22, 2025Output Problem; Output Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON 2025-07-01, TO REPORT THAT THE EXCOR BLOOD PUMP PU VALVES; 25ML WAS NOT FULLY EJECTING. THE SITE STATED THAT THEY HAD INCREASED THE SYSTOLIC DRIVING PRESSURE AND PERCENT SYSTOLE WITH NO CHANGE IN EJECTION. BHI CA ASSISTED IN PATIENT-RELATED TROUBLESHOOTING AND RECOMMENDED REPOSITIONING THE PATIENT AND OBTAINING AN ECHO TO EVALUATE THE CANNULA PLACEMENT. A CHEST CT WAS OBTAINED, AND WITHIN NORMAL LIMITS. THE SITE CHANGED THE PATIENT TO THE BACK-UP IKUS DRIVER, AND THE POOR EJECTING CONTINUED. A PUMP CHANGE WAS THEN PERFORMED TO RULE OUT PUMP-RELATED ISSUES. THE PUMP CHANGE WAS PERFORMED WITHOUT INCIDENT AND THE ISSUE WAS RESOLVED. PER THE SITE CONTACT, ONCE THE PUMP WAS REMOVED FROM THE PATIENT AND VISUALLY INSPECTED, THE MEMBRANE WAS NOTED TO BE "BALLOONED OUT ON BOTH SIDES LIKE IT WAS FULLY EJECTING AND FULLY FILLING AT THE SAME TIME".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565390 ↗
• 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. THE PATIENT'S LDH LEVELS INCREASED TO 3175 U/L AND PFHGB 120 MG/DL ON (B)(6) 2025. THE UPPER LIMIT OF NORMAL FOR LDH AT THIS SITE IS 376 AND FOR PFHGB IS 30 MG/DL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION. NO DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 22375857 ↗
• 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. THE PATIENT'S LDH LEVELS INCREASED TO 3175 U/L AND PFHGB 120 MG/DL ON (B)(6) 2025. THE UPPER LIMIT OF NORMAL FOR LDH AT THIS SITE IS 376 AND FOR PFHGB IS 30 MG/DL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION. NO DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 22375678 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS ON 2025-05-25 TO REPORT THAT THE PATIENT SUPPORTED WITH THE EXCOR SYSTEM IN BI-VAD CONFIGURATION EXPERIENCED HEMOLYSIS. THE PATIENT'S LDH LEVELS INCREASED TO 3000 U/L ON (B)(6) 2025. THE CLINIC DECIDED TO DECREASE THE RATE AND THE DIASTOLIC PRESSURES. THE LDH LEVEL THEN DECREASED TO 380 U/L AS OF (B)(6) 2025. THERE WERE NO VISIBLE DEPOSITS INSIDE OR OUTSIDE THE CANNULAS. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS PU VALVES; 25 ML IN/OUT; Ø 9 MM; LVAD, SN (B)(6) AND RVAD SN (B)(6) MAINTAINED COMPLETE FILLING AND EJECTION.

  Patient problems: Hemolysis

  MAUDE report 22293713 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS ON (B)(6) 2025 TO REPORT THAT THE PATIENT SUPPORTED WITH THE EXCOR SYSTEM IN BI-VAD CONFIGURATION EXPERIENCED HEMOLYSIS. THE PATIENT'S LDH LEVELS INCREASED TO 3000 U/L ON (B)(6) 2025. THE CLINIC DECIDED TO DECREASE THE RATE AND THE DIASTOLIC PRESSURES. THE LDH THEN DECREASED TO 380 U/L AS OF (B)(6) 2025. THERE WERE NO VISIBLE DEPOSITS INSIDE OR OUTSIDE THE CANNULAS. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS PU VALVES; 25 ML IN/OUT; Ø 9 MM; LVAD, SN (B)(6) AND RVAD SN (B)(6) MAINTAINED COMPLETE FILL AND EJECTION.

  Patient problems: Hemolysis

  MAUDE report 22289976 ↗
• InjuryApr 21, 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 THE EXCOR SYSTEM IN BI-VAD CONFIGURATION EXPERIENCED LEFT-SIDED WEAKNESS, SLURRED SPEECH AND HEADACHE ON (B)(6) 2025. A HEAD CT SCAN WAS PERFORMED AND CONFIRMED AN ISCHEMIC CVA ON THE RIGHT SIDE. THE PATIENT UNDERWENT AN IR THROMBECTOMY. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. FIBRIN WAS NOTED IN THE RVAD EXCOR BLOOD PUMP. THE CLINIC DECIDED NOT TO REPLACE THE PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 21877206 ↗
• InjuryApr 21, 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 THE EXCOR SYSTEM IN BI-VAD CONFIGURATION EXPERIENCED LEFT-SIDED WEAKNESS, SLURRED SPEECH AND HEADACHE ON (B)(6) 2025. A HEAD CT SCAN WAS PERFORMED AND CONFIRMED AN ISCHEMIC CVA ON THE RIGHT SIDE. THE PATIENT UNDERWENT AN IR THROMBECTOMY. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. FIBRIN WAS NOTED IN THE RVAD EXCOR BLOOD PUMP. THE CLINIC DECIDED NOT TO REPLACE THE PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 21877005 ↗
• InjuryMar 19, 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. THE PATIENT'S LDH LEVELS INCREASED FROM 684 U/L TO1800 U/L, AND PFHGB TO 7.4 MG/DL ON 2025-02-10. THE PRE PFHGB-WAS 10.6 MG/DL. THE PATIENT CONTINUES TO REMAIN ON THE SAME PUMP. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION. NO DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 21647640 ↗
• InjuryMar 19, 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. THE PATIENT'S LDH LEVELS INCREASED FROM 684 U/L TO1800 U/L, AND PFHGB TO 7.4 MG/DL ON (B)(6) 2025. THE PRE PFHGB WAS 10.6 MG/DL. THE PATIENT CONTINUES TO REMAIN ON THE SAME PUMP. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION. NO DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 21647462 ↗
• InjuryFeb 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 BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM HAD ELEVATED LDH LEVELS. THE PATIENT'S LDH VALUE SHOWED FROM 688 U/L TO 1523 U/L AND PLASMA FREE HEMOGLOBIN INCREASED FROM 3.0 MG/DL TO 9.9 MG/DL ON (B)(6) 2025. BOTH VALUES ARE 2.5 TIMES HIGHER THAN UPPER LIMITS OF NORMAL. THE SITE FURTHER REPORTED AN INCREASE IN TOTAL BILIRUBIN TO 6.4 MG/DL FROM BASELINE OF 1.7 MG/DL. THE SITE ALSO STATED THAT THE INCREASE IN THE ABNORMAL LAB VALUES WAS CONSIDERED TO BE MULTIFACTORIAL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM; SN (B)(6) FUNCTIONED AS INTENDED WITH COMPLETE FILLING AND EJECTION. THERE WERE NO DEPOSITS, OR ANY ABNORMAL SOUNDS NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 21462415 ↗
• InjuryFeb 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 2025-01-27 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM HAD ELEVATED LDH LEVELS. THE PATIENT'S LDH VALUE SHOWED FROM 688 U/L TO 1523 U/L AND PLASMA FREE HEMOGLOBIN INCREASED FROM 3.0 MG/DL TO 9.9 MG/DL ON (B)(6) 2025. BOTH VALUES ARE 2.5 TIMES HIGHER THAN UPPER LIMITS OF NORMAL. THE SITE FURTHER REPORTED AN INCREASE IN TOTAL BILIRUBIN TO 6.4 MG/DL FROM BASELINE OF 1.7 MG/DL. THE SITE ALSO STATED THAT THE INCREASE IN THE ABNORMAL LAB VALUES WAS CONSIDERED TO BE MULTIFACTORIAL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM; SN (B)(6) FUNCTIONED AS INTENDED WITH COMPLETE FILLING AND EJECTION. THERE WERE NO DEPOSITS, OR ANY ABNORMAL SOUNDS NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 21462296 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2024-12-26, A PHYSICIAN CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS TO REPORT THAT THE PATIENT, WHO WAS ORIGINALLY IMPLANTED ON (B)(6) 2024 WITH EXCOR SYSTEM IN BI-VAD CONFIGURATION, HAD A CARDIAC TAMPONADE AND WENT TO THE OPERATING ROOM ON (B)(6) 2024. THE SITE REPORTED THAT THE PROBLEM WAS OF HIGH C-REACTIVE PROTEIN (CRP) AND PROCALCITONIN, ALONG WITH NEGATIVE CULTURES. THE PATIENT EXPERIENCED AN ACUTE CARDIAC TAMPONADE SECONDARY TO SEPSIS. THE SITE ALSO REPORTED THAT THERE WERE PROBLEMS WITH FILLING IN LEFT EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM; LVAD SN (B)(6). BASED ON THE PATIENT'S HISTORY, THE PATIENT RECEIVED A BLOOD TRANSFUSION ON (B)(6) 2024 DUE TO THE DECREASE OF HEMOGLOBIN. THE PROBLEM WITH THE INCOMPLETE FILL OF THE PUMP WAS RESOLVED AND THE PATIENT RECOVERED. THE BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM: LVAD (SN (B)(6)) AND RVAD (SN (B)(6)) ARE STILL IN USE ON THE PATIENT SINCE (B)(6) 2024.

  Patient problems: Cardiac Tamponade

  MAUDE report 21218417 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2024-12-26, A PHYSICIAN CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS TO REPORT THAT THE PATIENT, WHO WAS ORIGINALLY IMPLANTED ON (B)(6) 2024 WITH EXCOR SYSTEM IN BI-VAD CONFIGURATION, HAD CARDIAC TAMPONADE AND WENT TO THE OR ON (B)(6) 2024. THE SITE REPORTED THAT THE PROBLEM WAS OF HIGH C-REACTIVE PROTEIN (CRP) AND PROCALCITONIN, ALONG WITH NEGATIVE CULTURES. THE PATIENT EXPERIENCED AN ACUTE CARDIAC TAMPONADE SECONDARY TO SEPSIS. THE SITE ALSO REPORTED THAT THERE WERE PROBLEMS WITH FILLING IN LEFT EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM; LVAD SN (B)(6). BASED ON THE PATIENT'S HISTORY, THE PATIENT RECEIVED A BLOOD TRANSFUSION ON (B)(6) 2024 DUE TO THE DECREASE OF HEMOGLOBIN. THE PROBLEM WITH THE INCOMPLETE FILL OF THE PUMP WAS RESOLVED AND THE PATIENT RECOVERED. THE BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM: LVAD (SN (B)(6) AND RVAD (SN (B)(6) ARE STILL IN USE ON THE PATIENT SINCE (B)(6) 2024.

  Patient problems: Cardiac Tamponade

  MAUDE report 21212161 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART GMBH WAS INFORMED BY THE DISTRIBUTOR THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM HAD DEVELOPED HEMOLYSIS. THE PATIENT WAS SWITCHED FROM THE EXCOR BLOOD PUMP TO A CENTRIFUGAL PUMP ON 2024-02-13. THE PATIENT CONTINUES TO USE THE EXCOR CANNULA. ACCORDING TO THE UPDATED INFORMATION FORM 2024-02-19, THE PATIENT WAS STABLE WITH DECREASING HEMOLYSIS.

  Patient problems: Hemolysis

  MAUDE report 18880806 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT THE BLOOD PUMP ON A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM DEVELOPED AN AUDIBLE "CRUNCHING SOUND'.ADDITIONAL INFORMATION PROVIDED BY THE SITE, ON 03-01-2024, REPORTED THAT THE PATIENT WAS EXHIBITED LDH LAB VALUES CONSISTENT WITH HEMOLYSIS. THE PATIENT'S LDH LEVEL INCREASED FROM 1636 ON (B)(6) 2024 TO 3557 ON (B)(6) 2024. ACCORDING TO THE SITE, THE BLOOD PUMP MAINTAINED COMPLETE FILLING AND EMPTYING THROUGHOUT.

  Patient problems: Hemolysis

  MAUDE report 18880769 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT THE BLOOD PUMP ON A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM DEVELOPED AN AUDIBLE "CRUNCHING SOUND'.ADDITIONAL INFORMATION PROVIDED BY THE SITE, ON 03-01-2024, REPORTED THAT THE PATIENT WAS EXHIBITED LDH LAB VALUES CONSISTENT WITH HEMOLYSIS. THE PATIENT'S LDH LEVEL INCREASED FROM 1636 ON (B)(6) 2024 TO 3557 ON (B)(6) 2024. ACCORDING TO THE SITE, THE BLOOD PUMP MAINTAINED COMPLETE FILLING AND EMPTYING THROUGHOUT.

  Patient problems: Hemolysis

  MAUDE report 18880726 ↗
• MalfunctionJan 22, 2024Output Problem; Output Problem

  BERLIN HEART CLINICAL AFFAIRS WAS INFORMED THAT THE CLINIC NOTED SUSPECTED PILLOW OF THE BLOOD PUMP MEMBRANE. THE CLINIC HAD EXCHANGED THE BLOOD PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18558867 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART GMBH WAS INFORMED BY THE CLINIC THAT THE PATIENT'S LDH LEVEL INCREASED TO 1836 ON 2023-12-04. THE CLINIC CONSIDERED THE POSSIBILITY THAT THE CAUSE COULD BE ATTRIBUTED TO THE PATIENT, SINCE THE PATIENT HAD A MECHANICAL VALVE IN HIS ATRIOVENTRICULAR VALVE THEREFORE, PERFORMED VARIOUS TESTS INCLUDING CT. THE RESULTS SHOWED NO ABNORMALITIES. THEREFORE, THE PUMP WAS REPLACED ON (B)(6) 2023 AND LDH VALUES DROPPED TO 1218.

  Patient problems: Hemolysis

  MAUDE report 18476281 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART CLINICAL AFFAIRS WAS INFORMED BY JAPAN DISTRIBUTOR THAT A PATIENT HAD A NEUROLOGICAL DYSFUNCTION SYMPTOM. SCHEDULED PUMP EXCHANGE DUE AFTER 1 YEAR OF USE OF THE PUMP WAS POSTPONED DUE TO THE PATIENT'S HEALTH CONDITION (SEVERE INFECTION). WHEN THE PATIENT BECAME STABLE THE PUMP WAS EXCHANGED ON (B)(6) 2023. HOWEVER, A THROMBUS WAS FOUND INSIDE THE NEW PUMP. THEREFORE, THE PUMP WAS CONVERTED FROM EXCOR TO CENTRIFUGAL PUMP (BIOFLOAT) ON (B)(6) 2023. AFTER CONVERSION, HEMIPLEGIA APPEARED ON (B)(6) 2023. TWO CT SCANS REVEALED AN ENLARGED CEREBRAL INFARCTION AND A WIDESPREAD BRAIN TUMOR.

  Patient problems: Convulsion/Seizure

  MAUDE report 18310964 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART INC. WAS INFORMED BY THE CLINIC THAT A PATIENT DEVELOPED LUE WEAKNESS. NO ACUTE INTERVENTIONS BUT RECOMMENDATION FROM NEUROLOGY TEAM WAS TO DECREASE PTT GOAL, HOLD ASA, MAINTAIN NORMOTHERMIA, NORMOTENSION, NORMOGLYCEMIA. THE PATIENT PREVIOUSLY NOTED TO HAVE STABLE PINPOINT THROMBIN DEPOSITS IN RVAD PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 18095183 ↗

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