EXCOR® P10P-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 04260090040102), received between Apr 5, 2016 and Sep 29, 2026 — classified as 1 death, 59 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Output Problem” (25 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 24, 2026Open, Classified

   Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

   Z-2320-2026 · Root cause: Error in labeling · FDA record ↗

2. 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Intravalvular regurgitation

  Patient problems: Hemolysis

  MAUDE report 50938599 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT A PATIENT UNDERWENT AN EXCOR BLOOD PUMP EXCHANGE DUE TO CLOT FORMATION ON THE POSTERIOR ASPECT OF THE OUTFLOW ON (B)(6) 2026. FOLLOWING COMPLETION OF THE PUMP EXCHANGE AND DRESSING CHANGE, THE PATIENT BECAME ACUTELY UNRESPONSIVE, WITH SIGNS OF POOR PERFUSION AND MINIMAL RESPIRATORY EFFORT. THE PATIENT WAS NOTED TO BE ACIDOTIC WITH A LACTATE OF 13 AND WAS SUBSEQUENTLY INTUBATED FOR RESPIRATORY FAILURE. HEAD CT AND HEAD ULTRASOUND WERE PERFORMED ON THE SAME DAY OF THE EVENT. THE CT RESULT SHOWED NEW HYPOATTENUATION OF THE LEFT CAUDATE HEAD/BASAL GANGLIA LIKELY REPRESENTING INTERVAL INFARCTION. NO EVIDENCE OF INTRACRANIAL HEMORRHAGE. NO SIGNIFICANT MASS EFFECT. THE HEAD ULTRASOUND DEMONSTRATED INCREASED ECHOGENICITY IN THE LEFT CAUDATE HEAD, CONCERNING FOR POSSIBLE ISCHEMIA. AN ADDITIONAL HEAD CT SHOWED INCREASED ECHOGENICITY IN THE LEFT CAUDATE HEAD, CONCERNING FOR POSSIBLE ISCHEMIA. THE EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM, S/N (B)(6) FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION. FIBRIN WAS NOTED AT THE OUTFLOW VALVE OF THE PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 25143929 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT A PATIENT UNDERWENT AN EXCOR BLOOD PUMP EXCHANGE DUE TO CLOT FORMATION ON THE POSTERIOR ASPECT OF THE OUTFLOW ON (B)(6) 2026. FOLLOWING COMPLETION OF THE PUMP EXCHANGE AND DRESSING CHANGE, THE PATIENT BECAME ACUTELY UNRESPONSIVE, WITH SIGNS OF POOR PERFUSION AND MINIMAL RESPIRATORY EFFORT. THE PATIENT WAS NOTED TO BE ACIDOTIC WITH A LACTATE OF 13 AND WAS SUBSEQUENTLY INTUBATED FOR RESPIRATORY FAILURE. HEAD CT AND HEAD ULTRASOUND WERE PERFORMED ON THE SAME DAY OF THE EVENT. THE CT RESULT SHOWED NEW HYPOATTENUATION OF THE LEFT CAUDATE HEAD/BASAL GANGLIA LIKELY REPRESENTING INTERVAL INFARCTION. NO EVIDENCE OF INTRACRANIAL HEMORRHAGE. NO SIGNIFICANT MASS EFFECT. THE HEAD ULTRASOUND DEMONSTRATED INCREASED ECHOGENICITY IN THE LEFT CAUDATE HEAD, CONCERNING FOR POSSIBLE ISCHEMIA. AN ADDITIONAL HEAD CT SHOWED INCREASED ECHOGENICITY IN THE LEFT CAUDATE HEAD, CONCERNING FOR POSSIBLE ISCHEMIA. THE EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM, S/N (B)(6) FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION. FIBRIN WAS NOTED AT THE OUTFLOW VALVE OF THE PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 25143840 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT A PATIENT EXPERIENCED INCREASED HEMOLYSIS ON (B)(6) 2026. THE HEMOLYSIS VALUES INCREASED TO THREE TIMES THE UPPER LIMIT OF NORMAL: LDH FROM 367 TO >1350, PFHGB > 50. THE EXCOR BLOOD PUMP CONTINUED TO FUNCTION AS INTENDED MAINTAINING COMPLETE FILLING AND EJECTION THROUGHOUT. NO DEPOSITS WERE NOTED IN THE PUMP.

  Patient problems: Hemolysis

  MAUDE report 25037605 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT A PATIENT EXPERIENCED INCREASED HEMOLYSIS ON (B)(6) 2026. THE HEMOLYSIS VALUES INCREASED TO THREE TIMES THE UPPER LIMIT OF NORMAL: LDH FROM 367 TO >1350, PFHGB > 50. THE EXCOR BLOOD PUMP CONTINUED TO FUNCTION AS INTENDED MAINTAINING COMPLETE FILLING AND EJECTION THROUGHOUT. NO DEPOSITS WERE NOTED IN THE PUMP.

  Patient problems: Hemolysis

  MAUDE report 25037563 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT A PATIENT WITH EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM, EXPERIENCED A NEUROLOGICAL EVENT ON (B)(6) 2026 THE PATIENT PRESENTED WITH WEAKNESS, GASTROINTESTINAL SYMPTOMS, MOSTLY VOMITING, THAT WORSENED ON (B)(6) 2026. MULTIPLE FIBRINS WERE NOTED IN THE CANNULA: CLUSTER FIBRIN AT THE OUTFLOW, SCATTERED FIBRIN IN THE SILICONE PART OF THE OUTFLOW CANNULA, ONE FLAPPING FIBRIN IN THE LV OUTFLOW CANNULA. THERE WERE 2 FLAPPING FIBRINS TO THE LV OUTFLOW CANNULA AND SMALL ADDITIONAL FIBRIN STRAND TO ANTERIOR ASPECT OF THE OUTFLOW CANNULA. HEAD AND NECK CT SCANS PERFORMED ON (B)(6) 2026 SHOWED MYCOTIC RUPTURED ANEURYSM, ACUTE THROMBUS/HYPERDENSE MCA. THERE WAS NO EVIDENCE OF LARGE VESSEL OCCLUSION. AFTER NEUROLOGICAL CONSULTATION, A NEURO ANGIOGRAM AS WELL AS AN INTRACRANIAL ANEURYSM COILING WERE SUBSEQUENTLY PERFORMED. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED MAINTAINING FULL FILLING AND EJECTION. MULTIPLE DEPOSITS WERE NOTED IN THE OUTFLOW CANNULA BEFORE AND AFTER THE EVENT.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 24983161 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2026-03-24 TO REPORT THAT A PATIENT WITH EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM, EXPERIENCED A NEUROLOGICAL EVENT ON (B)(6) 2026. THE PATIENT PRESENTED WITH WEAKNESS, GASTROINTESTINAL SYMPTOMS, MOSTLY VOMITING, THAT WORSENED ON (B)(6) 2026. MULTIPLE FIBRINS WERE NOTED IN THE CANNULA: CLUSTER FIBRIN AT THE OUTFLOW, SCATTERED FIBRIN IN THE SILICONE PART OF THE OUTFLOW CANNULA, ONE FLAPPING FIBRIN IN THE LV OUTFLOW CANNULA. THERE WERE 2 FLAPPING FIBRINS TO THE LV OUTFLOW CANNULA AND SMALL ADDITIONAL FIBRIN STRAND TO ANTERIOR ASPECT OF THE OUTFLOW CANNULA. HEAD AND NECK CT SCANS PERFORMED ON (B)(6) 2026 SHOWED MYCOTIC RUPTURED ANEURYSM, ACUTE THROMBUS/HYPERDENSE MCA. THERE WAS NO EVIDENCE OF LARGE VESSEL OCCLUSION. AFTER NEUROLOGICAL CONSULTATION, A NEURO ANGIOGRAM AS WELL AS AN INTRACRANIAL ANEURYSM COILING WERE SUBSEQUENTLY PERFORMED. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED MAINTAINING FULL FILLING AND EJECTION. MULTIPLE DEPOSITS WERE NOTED IN THE OUTFLOW CANNULA BEFORE AND AFTER THE EVENT.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 24982976 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2026-01-21 TO REPORT THAT THE PATIENT WAS PRESENTED WITH FACIAL TWITCHING AND EYE DEVIATION ON (B)(6) 2026. HEAD CT PERFORMED ON THE SAME DAY SHOWED A SUBACUTE INFARCT IN THE LEFT FRONTAL LOBE IN THE DISTRIBUTION OF THE ANTERIOR DIVISION OF THE LEFT MIDDLE CEREBRAL ARTERY. THERE ARE SMALL AREAS OF SUBACUTE INFARCTS SEEN IN A PARAMEDIAN LOCATION OF THE RIGHT CEREBRAL HEMISPHERE CONSISTENT WITH WATERSHED TERRITORY INFARCTS. THERE IS NO INTRAPARENCHYMAL HEMORRHAGE, MASS, OR MIDLINE SHIFT. THERE IS NO HYDROCEPHALUS OR EXTRACEREBRAL FLUID COLLECTION. THE CALVARIUM IS INTACT. THE VISUALIZED PORTIONS OF THE ORBITS, PARANASAL SINUSES, MASTOID AIR CELLS, AND SELLA ARE NORMAL. CRANIAL ULTRASOUND SHOWED NO ABNORMALITIES. UPON EEG FINDINGS, THERE WERE NUMEROUS ELECTROGRAPHIC SEIZURES INDEPENDENTLY ARISING FROM RIGHT AND LEFT CENTRAL HEAD REGION. THESE SEIZURES OCCURRED AT A FREQUENCY OF ONCE IN 2 HOURS WITH THE LAST SEIZURES OCCURRED AT THE PREVIOUS EVENT. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED MAINTAINING FULL FILL AND EJECT. DEPOSITS WERE NOTED IN THE PUMP BEFORE AND AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 24309073 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED (B)(6) CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT THE PATIENT WAS PRESENTED WITH FACIAL TWITCHING AND EYE DEVIATION ON (B)(6) 2026. HEAD CT PERFORMED ON THE SAME DAY SHOWED A SUBACUTE INFARCT IN THE LEFT FRONTAL LOBE IN THE DISTRIBUTION OF THE ANTERIOR DIVISION OF THE LEFT MIDDLE CEREBRAL ARTERY. THERE ARE SMALL AREAS OF SUBACUTE INFARCTS SEEN IN A PARAMEDIAN LOCATION OF THE RIGHT CEREBRAL HEMISPHERE CONSISTENT WITH WATERSHED TERRITORY INFARCTS. THERE IS NO INTRAPARENCHYMAL HEMORRHAGE, MASS, OR MIDLINE SHIFT. THERE IS NO HYDROCEPHALUS OR EXTRACEREBRAL FLUID COLLECTION. THE CALVARIUM IS INTACT. THE VISUALIZED PORTIONS OF THE ORBITS, PARANASAL SINUSES, MASTOID AIR CELLS, AND SELLA ARE NORMAL. CRANIAL ULTRASOUND SHOWED NO ABNORMALITIES. UPON EEG FINDINGS, THERE WERE NUMEROUS ELECTROGRAPHIC SEIZURES INDEPENDENTLY ARISING FROM RIGHT AND LEFT CENTRAL HEAD REGION. THESE SEIZURES OCCURRED AT A FREQUENCY OF ONCE IN 2 HOURS WITH THE LAST SEIZURES OCCURRED AT THE PREVIOUS EVENT. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED MAINTAINING FULL FILL AND EJECT. DEPOSITS WERE NOTED IN THE PUMP BEFORE AND AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 24309028 ↗
• InjuryJan 8, 2026Noise, Audible

  BERLIN HEART CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC ABOUT A NOISY EXCOR BLOOD PUMP. THE EXCOR BLOOD PUMP WAS EXCHANGED ON (B)(6) 2025. THE PATIENT'S HEALTH DETERIORATED AT THE TIME OF THE EVENT. THE NEXT DAY, THE PATIENT WAS STABLE. THE BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT. FURTHER ON THE CLINIC INFORMED THAT THE PATIENT SHOWED SIGNS OF HEMOLYSIS WITH OBSERVED LDH VALVES OF 1131 U/L, AND THAT THE PATIENT HAS BEEN TRANSFUSED FOR THE THIRD TIME. BERLIN HEART WAS NOTIFIED BY THE CLINIC, THAT THE HEMOLYSIS VALUES WENT BACK TO NORMAL AFTER THE EXCHANGE OF THE BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 24005642 ↗
• DeathJul 25, 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 ITALIAN DISTRIBUTOR ON 2025-07-08 THAT A PATIENT WITH EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM; SUFFERED CEREBRAL HEMORRHAGE AND WAS DECEASED ON (B)(6) 2025. THE PATIENT'S DEATH WAS NOT CAUSED BY A THROMBUS IN THE EXCOR PUMP. IT WAS DUE TO A SERIES OF COMPLICATIONS / EVENTS.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22610323 ↗
• InjuryJul 8, 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 2025-06-25 TO REPORT THAT THE PATIENT SUPPORTED WITH THE EXCOR SYSTEM IN BI-VAD CONFIGURATION HAD AN EPISODE OF RIGHT SIDED RHYTHMIC FACIAL TWITCHING AND RIGHT FACIAL DROOP. HEAD CT OBTAINED ON (B)(6) 2025 SHOWED ACUTE TO SUBACUTE LEFT FRONTAL AND INSULAR INFARCT. THE BERLIN HEART EXCOR BLOOD PUMPS FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING AND EJECTION THROUGHOUT. TWO SMALL PUNCTUAL DEPOSITS WERE NOTED IN THE OUTFLOW VALVE OF THE LEFT PUMP (LVAD, SN (B)(6) PRIOR TO THE EVENT, AND ONE SMALL PUNCTUAL DEPOSIT WAS NOTED IN THE OUTFLOW VALVE OF THE LEFT PUMP AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 22442603 ↗
• InjuryJul 8, 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 HAD AN EPISODE OF RIGHT SIDED RHYTHMIC FACIAL TWITCHING AND RIGHT FACIAL DROOP. HEAD CT OBTAINED ON (B)(6) 2025 SHOWED ACUTE TO SUBACUTE LEFT FRONTAL AND INSULAR INFARCT. THE BERLIN HEART EXCOR BLOOD PUMPS FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING AND EJECTION THROUGHOUT. TWO SMALL PUNCTUAL DEPOSITS WERE NOTED IN THE OUTFLOW VALVE OF THE LEFT PUMP (LVAD, SN (B)(6) PRIOR TO THE EVENT, AND ONE SMALL PUNCTUAL DEPOSIT WAS NOTED IN THE OUTFLOW VALVE OF THE LEFT PUMP AFTER THE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 22442157 ↗
• InjuryMay 22, 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 2148 U/L AND PFHGB 77.6 MG/DL ON (B)(6) 2025. THE RATE ON THE EXCOR ACTIVE DRIVING UNIT WAS DECREASED AT THE TIME OF THE EVENT. REPEATED LAB VALUES SHOWED CONTINUED HEMOLYSIS AND THE PATIENT WAS TRANSITIONED TO CONTINUOUS FLOW ON (B)(6) 2025. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION.

  Patient problems: Hemolysis

  MAUDE report 22071139 ↗
• InjuryMay 22, 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 2025-05-12 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM EXPERIENCED HEMOLYSIS. THE PATIENT'S LDH LEVELS INCREASED TO 2148 U/L AND PFHGB 77.6 MG/DL ON (B)(6) 2025. THE RATE ON THE EXCOR ACTIVE DRIVING UNIT WAS DECREASED AT THE TIME OF THE EVENT. REPEATED LAB VALUES SHOWED CONTINUED HEMOLYSIS AND THE PATIENT WAS TRANSITIONED TO CONTINUOUS FLOW ON (B)(6) 2025. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION.

  Patient problems: Hemolysis

  MAUDE report 22070659 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM ON (B)(6) 2025 HAD DEVELOPED LEFT SIDED WEAKNESS AND THEIR PUPILS WERE NOT EQUAL IN SIZE AND REACTIVITY. LATER THAT SAME DAY THE PATIENT DEVELOPED SEIZURES. THE PATIENT WAS INTUBATED AND THEN UNDERWENT A HEAD CT AND EEG. THE CT SCAN SHOWED A HEMORRHAGIC INFARCT, AND THE EEG SHOWED SEIZURES. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. DEPOSITS WERE NOTED ON THE PUMP WIDE WALL AND THE OUTFLOW/INFLOW AREAS. THE PATIENT CONTINUES TO REMAIN ON THE SAME BLOOD PUMP.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 22014333 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM ON (B)(6) 2025 HAD DEVELOPED LEFT SIDED WEAKNESS AND THEIR PUPILS WERE NOT EQUAL IN SIZE AND REACTIVITY. LATER THAT SAME DAY THE PATIENT DEVELOPED SEIZURES. THE PATIENT WAS INTUBATED AND THEN UNDERWENT A HEAD CT AND EEG. THE CT SCAN SHOWED A HEMORRHAGIC INFARCT, AND THE EEG SHOWED SEIZURES. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. DEPOSITS WERE NOTED ON THE PUMP WIDE WALL AND THE OUTFLOW/INFLOW AREAS. THE PATIENT CONTINUES TO REMAIN ON THE SAME BLOOD PUMP.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 22014191 ↗
• 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 2025-03-27 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM PRESENTED WITH A RIGHT ARM AND FACIAL TWITCHING AND SEIZURE LIKE ACTIVITY ON (B)(6) 2025..CT SCAN SHOWED SUBACUTE LEFT MCA TERRITORY STROKE. AN ADDITIONAL CT SCAN RESULT SHOWED THE EXPECTED EVOLUTION OF SUBACUTE LEFT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY INFARCT WITH NO HEMORRHAGE. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 21875115 ↗
• 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 2025-03-27 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM PRESENTED WITH A RIGHT ARM AND FACIAL TWITCHING AND SEIZURE LIKE ACTIVITY ON (B)(6) 2025. CT SCAN SHOWED SUBACUTE LEFT MCA TERRITORY STROKE. AN ADDITIONAL CT SCAN RESULT SHOWED THE EXPECTED EVOLUTION OF SUBACUTE LEFT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY INFARCT WITH NO HEMORRHAGE. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PERFORMED AS INTENDED WITH COMPLETE FILLING AND EJECTION. DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 21874533 ↗
• MalfunctionMar 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  (B)(6) 2025, THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT DURING TRANSFER OF THE PATIENT FROM THE OR TO THE ICU, THE SITE NOTICED BLOOD BETWEEN THE MEMBRANE LAYERS AROUND THE STABILIZATION RING ON THE EXCOR BLOOD PUMP PU VALVES; 10 ML. THE SITE REPORTED THAT THE BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THIS TIME. UPON EVALUATING THE VIDEO PROVIDED BY THE SITE, BHI CA RECOMMENDED A PUMP CHANGE. THE SITE CHANGED THE BLOOD PUMP WITHOUT ANY SIGNIFICANT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682981 ↗
• InjuryMar 24, 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 CONTINUED TO HAVE HEMOLYSIS SINCE THE IMPLANT ON (B)(6) 2025. THE LDH VALUE SHOWED >1000 U/L, WHICH IS 2.5 TIMES HIGHER THAN UPPER LIMITS OF NORMAL AND PLASMA FREE HEMOGLOBIN VALUE WAS ALSO NOTED TO BE 2.5 TIMES HIGHER THAN UPPER LIMITS OF NORMAL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM; SN (B)(6) PERFORMED AS INTENDED WITH COMPLETE FILL AND EJECTION. THERE WERE NO ABNORMAL SOUNDS FROM THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 21682369 ↗
• 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 2025-01-28 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM CONTINUED TO HAVE HEMOLYSIS SINCE THE IMPLANT ON (B)(6) 2025. THE LDH VALUE SHOWED >1000 U/L, WHICH IS 2.5 TIMES HIGHER THAN UPPER LIMITS OF NORMAL AND PLASMA FREE HEMOGLOBIN VALUE WAS ALSO NOTED TO BE 2.5 TIMES HIGHER THAN UPPER LIMITS OF NORMAL. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM; SN (B)(6) PERFORMED AS INTENDED WITH COMPLETE FILL AND EJECTION. THERE WERE NO ABNORMAL SOUNDS FROM THE EXCOR BLOOD PUMP.

  Patient problems: Hemolysis

  MAUDE report 21462658 ↗
• MalfunctionDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS TO REPORT DIASTOLIC REGURGITATION WITH THRILL ON THE OUTLET OF BOTH PUMPS AS THE ULTRASOUND SONOGRAPHY (USG) SHOWED LEAKING OF THE OUTFLOW VALVE. ACCORDING TO THE SITE, THE PATIENT HAD EXPERIENCED HEMOLYSIS SINCE IMPLANTATION. THE PATIENT IS TRANSFUSION DEPENDENT WITH ELEVATED LDH VALUE. THE PATIENT IS CLINICALLY STABLE THROUGHOUT. BH CA RECOMMENDED A PUMP CHANGE, HOWEVER, THE SITE STATED THAT THEY WOULD CLOSELY MONITOR THE PATIENT. THE PATIENT IS BEING SUPPORTED WITH AN EXCOR SYSTEM IN BI-VAD CONFIGURATION. BOTH PUMPS ARE BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM: LVAD (SN (B)(6) AND RVAD (SN (B)(6) AND ARE STILL IN USE ON THE PATIENT SINCE 2024-10-18.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21027293 ↗
• MalfunctionDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS TO REPORT DIASTOLIC REGURGITATION WITH THRILL ON THE OUTLET OF BOTH PUMPS AS THE ULTRASOUND SONOGRAPHY (USG) SHOWED LEAKING OF THE OUTFLOW VALVE. ACCORDING TO THE SITE, THE PATIENT HAD EXPERIENCED HEMOLYSIS SINCE IMPLANTATION. THE PATIENT IS TRANSFUSION DEPENDENT WITH ELEVATED LDH VALUE. THE PATIENT IS CLINICALLY STABLE THROUGHOUT. BH CA RECOMMENDED A PUMP CHANGE, HOWEVER, THE SITE STATED THAT THEY WOULD CLOSELY MONITOR THE PATIENT. THE PATIENT IS BEING SUPPORTED WITH AN EXCOR SYSTEM IN BI-VAD CONFIGURATION. BOTH PUMPS ARE BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM: LVAD (SN (B)(6)) AND RVAD (SN (B)(6)) AND ARE STILL IN USE ON THE PATIENT SINCE (B)(6) 2024.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21027069 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2024-11-22 THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT HAD BRIEF EPISODES OF LEFT UPPER EXTREMITY (LUE) AND LEFT LOWER EXTREMITY (LLE) RHYTHMIC MOVEMENTS LASTING < 10 SECONDS ON (B)(6) 2024. THE NEXT DAY ( (B)(6) 2024 ), THE PATIENT HAD SIMILAR EPISODES AS WELL AS A 15-20 SECONDS EPISODE OF BILATERAL UPPER EXTREMELY JERKING AS WITNESS BY PRIMARY TEAM. HEAD CT SCANS WITHOUT CONTRAST REVEALED RIGHT FRONTAL-PARIETAL AND LEFT FRONTAL AND OCCIPITAL HYPODENSITIES CONSISTENT WITH SUBACUTE INFARCTS. ACCORDING TO THE SITE, THE BERLIN HEART EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM FUNCTIONED AS INTENDED, WITH COMPLETE FILL AND EJECTION. MULTIPLE DEPOSITS WERE NOTED IN THE PUMP.

  Patient problems: Ischemia Stroke

  MAUDE report 20896675 ↗