EXCOR® C23V-004mRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260090041291), received between Jan 19, 2023 and Nov 24, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON 2025-11-05 THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT THAT A PUMP CHANGE OCCURRED ON (B)(6) 2025 DUE TO CONCERN REGARDING THE DISTAL END OF THE INFLOW EXCOR ATRIAL CANNULA FOR CHILDREN Ø 12/9 MM, WHICH APPEARED "STRESSED" AND BUDDED UNDER THE CABLE TIE. ACCORDING TO THE SITE CONTACT, THE AFFECTED PORTION OF THE CANNULA WAS CUT AND DISCARDED, AND A NEW EXCOR CANNULA EXTENSION SET Ø 9/9 MM AND BLOOD PUMP WERE SUCCESSFULLY PLACED WITHOUT ANY ADVERSE EVENTS. WHEN QUESTIONED ABOUT THE CABLE TIE GUN SETTING, THE SITE CONFIRMED THAT NO ADJUSTMENTS WERE MADE AND THAT IT REMAINS ON THE ORIGINAL, RECOMMENDED SETTING. PRIOR TO THE EXCHANGE, THE BLOOD PUMP DEMONSTRATED COMPLETE FILLING AND EJECTION, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. ALTHOUGH THIS EVENT HAD NO NEGATIVE EFFECT ON THE PATIENT, THIS KIND OF DEFECT COULD POTENTIALLY RESULT IN A DISRUPTION OF THE CANNULA. THEREFORE, BERLIN HEART DECIDED TO REPORT THIS EVENT DUE TO CONCERNS ABOUT THE POSSIBLE RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632763 ↗
• MalfunctionMay 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, THE SITE CONTACTED (B)(6) INC. CLINICAL AFFAIRS (CA) TO REPORT THAT A CALL WAS RECEIVED FROM THE PATIENT'S BEDSIDE NURSE WITH CONCERNS ABOUT AN AREA ON THE INFLOW EXCOR ATRIAL CANNULA Ø 12/9 MM; L 32 CM; HEAD 23MM (LOT: 00119829). THE IMPLANTING SURGEON ASSESSED THE PATIENT BEDSIDE AND MADE THE DECISION TO UPGRADE THE PATIENT TO ICU TO EXCISE THE CONCERNING AREA OF THE CANNULA. DURING TRANSPORT, THE PATIENT BEGAN HAVING A SEIZURE. AFTER THE SEIZURE ENDED, A DROP OF BLOOD WAS NOTICED ON THE OUTSIDE OF THE CANNULA AT THE LEVEL OF THE TITANIUM PUMP STUB. THE CANNULAS WERE CLAMPED, THE AFFECTED PORTION OF THE CANNULA AND EXCOR BLOOD PUMP WERE REMOVED, AND THE PATIENT WAS PLACED ON ECMO. THE PATIENT WAS THEN TAKEN FOR A HEAD CT WHICH WAS NEGATIVE FOR ANY ACUTE EVENTS. AFTER RETURNING FROM CT, THE SITE REPORTS THAT THE PATIENT BEGAN WAKING UP AND WAS APPROPRIATE IN MOVEMENT AND SPEECH. THE SITE PROVIDED A VIDEO OF THE PUMP AND CANNULA PORTION THAT WAS REMOVED. ON (B)(6) 2025, THE PATIENT WAS SWITCHED FROM ECMO TO AN EXCOR BLOOD PUMP.

  Patient problems: Convulsion/Seizure

  MAUDE report 21950161 ↗
• MalfunctionOct 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2023, THE SITE REPORTED THAT A KINK WAS OBSERVED IN THE INFLOW CANNULA OF A PATIENT. IT HAD BEEN PRESENT FOR A FEW DAYS WITHOUT BEING REPORTED TO THE BERLIN HEART INC. CLINICAL AFFAIRS (CA) TEAM. CA REQUESTED PICTURES TO ASSESS THE KINK. UPON REVIEWING THE PICTURES, CA RECOMMENDED TRIMMING OFF THE INFLOW CANNULA WITH THE CONFIRMED KINK. ADDITIONALLY, AT THE TIME OF THE EVENT THE BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION, NO CANNULA BREACH AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THEREFORE, IT WAS DECIDED THIS INCIDENT WAS NOT REPORTABLE. HOWEVER, AFTER COMPLETING THE FAILURE INVESTIGATION ON 2023-10-12, IT WAS DETERMINED THAT IT WAS NOT A KINK, IT WAS A CUT OUTSIDE THE CANNULA. THEREFORE, IT WAS DETERMINED THIS WAS REPORTABLE AS MDR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953684 ↗
• MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  SITE CONTACTED BERLIN HEART, INC (BHI) ON (B)(6) 2023 TO REPORT A DISRUPTION IN THE INFLOW CANNULA AT THE INFLOW CONNECTION OF THE BLOOD PUMP. BY REPORT, THE NURSE WAS CALLED INTO THE PATIENT'S ROOM BY THE PATIENT'S PARENT AND NOTED A LARGE AMOUNT OF BLOOD IN THE BED. SURGICAL TEAM WAS CALLED TO THE BEDSIDE AND THE CANNULAS WERE CLAMPED AND THE IKUS WAS STOPPED. PATIENT WAS EMERGENTLY TRANSITIONED TO ECMO SUPPORT VIA BERLIN HEART CANNULAE. SITE REPORTED THAT THE DAMAGED PORTION OF THE CANNULA WAS CUT OFF AND REMOVED WITH THE EXCOR BLOOD PUMP PRIOR TO THE TRANSITION TO ECMO SUPPORT. BERLIN HEART CLINICAL AFFAIRS REQUESTED THAT THE DAMAGED PORTION OF THE CANNULA AND THE BLOOD PUMP BE RETURNED TO BHI FOR EVALUATION. HOWEVER, SITE INFORMED BHI THAT THE CANNULA AND BLOOD PUMP WILL BE RETAINED BY THE SITE FOR THIRD-PARTY EVALUATION, AND THUS, THEY WILL NOT BE RETURNED TO BHI.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16208927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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
• Z-1618-2023 · May 18, 2018 · Terminated
  EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood