EXCOR® P60P-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04260090040027), received between Nov 15, 2018 and Sep 5, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 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 (B)(6) 2025 THAT THE PATIENT ON BVAD, HAD SUFFERED AN ISCHEMIC STROKE SHORTLY AFTER RE-OPERATION BECAUSE OF RETROSTERNAL COLLECTION. VERY LITTLE FIBRIN SPOTS WERE SEEN IN BOTH EXCOR BLOOD PUMPS. THE PATIENT WAS ON ECMO SUPPORT FOR SEVERAL DAYS PRIOR TO THE IMPLANT OF THE BERLIN HEART EXCOR SYSTEM. THE BLOOD PUMPS PERFORMED AS INTENDED.

  Patient problems: Ischemia Stroke

  MAUDE report 22978530 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART WAS INFORMED ON (B)(6) 2023 THAT THE PATIENT IN EXCOR SYSTEM DEVELOPED HEMOLYSIS. ON (B)(6) 2023, THE PATIENT'S LDH VALUES INCREASED TO 3900, AND HAPTOGLOBIN <7 MG/DL. IN THE ECHOCARDIOGRAPHY OF THE OUTFLOW CANNULA ON THE ASCENDING AORTA APPEARED NARROW, WITH A MEAN PRESSURE GRADIENT OF 70MMHG. THIS FINDING INDICATES STENOSIS AND COULD BE THE REASON FOR THE ELEVATED HEMOLYSIS AND RELATIVELY HIGH SYSTOLIC DRIVING PRESSURE OF THE LVAD.

  Patient problems: Hemolysis

  MAUDE report 17354099 ↗
• MalfunctionJun 1, 2023Output Problem; Output Problem

  BERLIN HEART WAS INFORMED BY THE CLINIC THAT EXCOR MOBILE DRIVING UNIT EMITTED AN ALARM ABOUT THE PRESSURE LOSS. A VAD COORDINATOR IN THE CLINIC DETECTED A DEFECT AT THE BARB CONNECTOR FOR THE DRIVING TUBE OF THE EXCO BLOOD PUMP. THE PATIENT WAS CLINICALLY STABLE. THE CLINIC CHANGED THE BLOOD PUMP ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038793 ↗
• MalfunctionAug 13, 2019Particulates; Particulates

  WE WERE INFORMED ABOUT INCREASED GRAPHITE DEPOSITS IN THE AIR CHAMBER OF THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BIVAD CONFIGURATION. UPON EVALUATION OF VIDEOS FROM THE CLINIC, BERLIN HEART RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP. TRAINED PERSONNEL AT THE CLINIC PERFORMED AN EXCHANGE OF THE AFFECTED BLOOD PUMP ON (B)(6) 2019. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT WAS DOING WELL AGAIN AFTER THE EXCHANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888363 ↗
• MalfunctionMay 17, 2019Output Problem; Output Problem

  BERLIN HEART INC. WAS CONTACTED BY THE CLINIC REGARDING THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE CLINIC NOTED THAT THE PUMP APPEARED TO BE INCOMPLETELY FILLING AND EMPTYING AT THE TIME OF THE INCIDENT. THE CLINIC DECIDED TO TRANSFER THE PATIENT FROM HER EXCOR MOBILE DRIVING UNIT TO A STATIONARY DRIVING UNIT IKUS. HOWEVER, THIS DID NOT IMPROVE THE EJECTION. THE CLINIC THEN PROVIDED BERLIN HEART INC. CA WITH A VIDEO OF THE BLOOD PUMP. UPON EVALUATION, AN IMMEDIATE EXCHANGE WAS RECOMMENDED. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS BY TRAINED PERSONNEL AT THE CLINIC. THE PATIENT WAS NOT AFFECTED BY THE INCIDENT AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619537 ↗
• MalfunctionNov 15, 2018Leak/Splash; Leak/Splash

  WE WERE CONTACTED BY THE CLINIC WHO REPORTED THAT THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION APPEARED TO HAVE A LEAK AT THE JUNCTION BETWEEN THE BLOOD PUMP AND THE DRIVING TUBE, AT THE CONNECTOR REGION. THE AFFECTED BLOOD PUMP WAS EXCHANGED BY TRAINED PROFESSIONALS AT THE CLINIC IN THE EARLY MORNING HOURS OF (B)(6) 2018. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073976 ↗

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