EXCOR® C18A-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04260090040515), received between Dec 3, 2019 and Mar 3, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Fracture

  THE CLINIC CONTACTED BERLIN HEART CLINICAL AFFAIRS ON (B)(6) 2025, TO REPORT A CRACK OBSERVED ON THE INFLOW CANNULA. THERE WAS PULSATILE BLEEDING AND SQUIRTING OF BLOOD. THE AFFECTED PIECE OF THE CANNULA WAS CUT OFF AND A NEW PUMP WAS USED. IT WAS INFORMED THAT THE PATIENT HAD NO NEGATIVE EFFECT DUE TO THE EVENT. ACCORDING TO ADDITIONAL INFORMATION FROM THE CLINIC, THE PATIENT TEMPORARILY EXPERIENCED ARM WEAKNESS ON THE SAME DAY. A CT SCAN SHOWED A STROKE AND CONVULSIONS. NO CHANGE IN THE TREATMENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CLINIC FURTHER INFORMED THAT THE PATIENT HAS REMAINED CLINICALLY STABLE THROUGHOUT.

  Patient problems: Stroke/CVA

  MAUDE report 24498534 ↗
• MalfunctionFeb 26, 2026Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT AN EXTERNAL SCRATCH THAT WAS NOTED IN THE EXCOR APEX CANNULA FOR SMALL CHILDREN. OF NOTE, THE SITE REPORTED THE DEFECT AS AN "EXTERNAL CRACK". UPON REVIEWING THE PICTURE AND A VIDEO PROVIDED BY THE SITE, CA CONFIRMED AN EXTERNAL, PALPABLE, HORIZONTAL SCRATCH DIRECTLY BELOW THE VELOUR. THE SITE EXPLAINED THAT THE SCRATCH WAS FIRST NOTICED THE NIGHT PRIOR AND HAD GROWN IN LENGTH. THEREFORE, BHI CA ADVISED TRIMMING THE CANNULA ABOVE THE DEFECT, AND ADDING IN A CONNECTOR AND AN EXTENSION SET. BHI CA ALSO ADVISED DOING THIS ON BOTH SIDES OF THE PUMP TO ENSURE ADEQUATE LENGTH ON BOTH SIDES OF THE CANNULA. OF NOTE, THE SITE CHOSE TO TRIM THE AFFECTED SECTION OF THE CANNULA AND ADDED ONLY ONE CONNECTOR. AFTER THE CANNULA WAS TRIMMED THE PUMP LEVEL WAS OBSERVED TO BE EVEN AND THE CANNULA INTEGRITY ISSUE WAS RESOLVED. THE EXCOR BLOOD PUMP CONTINUED TO FUNCTION AS INTENDED, MAINTAINING FULL FILL AND EJECTION THROUGHOUT. AT THE TIME OF THE EVENT, THE LENGTH OF THE CANNULAS WERE NOT SYMMETRICAL, BUT THE DISTANCE BETWEEN THE TITANIUM CONNECTORS WERE WITHIN THE RECOMMENDATIONS OF THE IFU. THE EXCOR CABLE TIES WERE POSITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24459363 ↗
• MalfunctionDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE NOTIFIED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) VIA EMAIL ON 2025-12-01 THAT A EXCOR APEX CANNULA DISRUPTION OCCURRED ON (B)(6) 2025. BHI CA CALLED THE SITE TO GET ADDITIONAL INFORMATION. THE SITE REPORTED THAT DURING A ROUTINE PUMP ASSESSMENT, THE RN LIFTED THE PUMP, TWISTING IT SLIGHTLY TO ASSESS THE MEMBRANE MOVEMENT. WHEN THE RN LIFTED THE PUMP, A SPRAY OF BLOOD CAME FROM THE INFLOW CANNULA. THE CANNULAS WERE IMMEDIATELY CLAMPED, AND BLOOD WAS NOTED ON THE EXTERIOR SIDE OF INFLOW CANNULA. NO AIR WAS NOTED IN THE PUMP. THE BLOOD PUMP WAS DISCONNECTED, AND THE CANNULAS WERE EXAMINED BY THE SURGEON. NO AREA OF COMPROMISE WAS VISIBLE ON THE INFLOW CANNULA, AND BOTH CANNULAS WERE TRIMMED OUT OF AN ABUNDANCE OF CAUTION. THE BLOOD PUMP WAS RECONNECTED WITHOUT INCIDENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT, AND ALL ASSESSMENTS ARE WITHIN NORMAL LIMITS (WNL). AT THE TIME OF THE REPORT, THE TRIMMED PORTION OF THE CANNULAS HAD BEEN DISCARDED AND COULD NOT BE RETURNED. THE SITE ALSO REPORTED THAT ALL ZIP TIES WERE SECURELY IN PLACE AT THE TIME OF THE EVENT, AND THAT ALL CANNULA LENGTHS WERE WITHIN THE RECOMMENDED SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849905 ↗
• MalfunctionDec 9, 2025Scratched Material; Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE BLOOD PUMP WAS CHANGED ON (B)(6) 2025 DUE TO AN EXTERNAL SCRATCH NOTED ON THE EXCOR ATRIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM IN LVAD NEAR THE METAL CONNECTION. THE CANNULA SEGMENT WAS REMOVED AT THE TIME OF PUMP CHANGE. THE SITE REPORTED THAT THE EXCISED PORTION OF THE CANNULA WAS DISCARDED PRIOR TO NOTIFICATION OF BHI CA. PER THE SITE, THE BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756871 ↗
• MalfunctionMay 16, 2025Fracture; Fracture

  ON 2025-05-11 THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT AN INFLOW CANNULA BREACH ON THE PATIENT WHO WAS ORIGINALLY IMPLANTED ONLY WITH EXCOR APEX CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM. SUBSEQUENTLY, THE PATIENT WAS SUPPORTED WITH A EXCOR PEDIATRIC VAD WITH EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM. THE INITIAL REPORTER ON (B)(6) 2025 DESCRIBED THAT THE PATIENT WAS SITTING UP IN BED WHEN BLOOD WAS NOTICED ON HER CLOTHING BY THE BEDSIDE STAFF. DURING THE ASSESSMENT TO FIND THE SOURCE OF THE BLOOD, THE PATIENT VOMITED AND BEGAN HAVING A SEIZURE. AFTER REMOVING THE PATIENT'S CLOTHES, A VISIBLE "SPLIT" WAS NOTED IN THE INFLOW CANNULA. AIR WAS NOTED IN THE CANNULA. BOTH THE INFLOW AND OUTFLOW CANNULAS WERE CLAMPED, AND THE DRIVING TUBE WAS DISCONNECTED FROM THE EXCOR IKUS DRIVING UNIT. AT THIS TIME THE PATIENT LOST PULSES. DESPITE RESUSCITATION EFFORTS, THE PATIENT DIED.

  Patient problems: Convulsion/Seizure

  MAUDE report 22039169 ↗
• MalfunctionApr 18, 2023Fracture; Fracture

  BERLIN HEART CLINICAL AFFAIRS WAS INFORMED BY OUR DISTRIBUTOR THAT ON (B)(6) 2023 A RUPTURE HAD BEEN DETECTED IN THE INFLOW CANNULA. THE PATIENT WAS PLACED ON ECMO TO STABILIZE THEIR CONDITION. THE DISTRIBUTOR FURTHER INFORMED US ON APRIL 1ST, 2023, THAT THE MOTHER WAS PRESENT WITH THE PATIENT WHEN THE EVENT OCCURRED, AND THERE WAS SIGNIFICANT BLEEDING FROM THE INFLOW CANNULA. CPR WAS PERFORMED UNSUCCESSFULLY AND ACCORDING TO THE SITE, PATIENT EXPIRED. BERLIN HEART CLINICAL AFFAIRS HAS REQUESTED THAT THE AFFECTED CANNULA-PUMP-SYSTEM BE RETURNED TO BERLIN HEART FOR FURTHER INVESTIGATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16765375 ↗
• MalfunctionFeb 2, 2021Material Puncture/Hole; Material Puncture/Hole

  WE WERE INFORMED BY THE CLINIC ABOUT A SMALL CRACK IN THE APEX CANNULA OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC REPORTED BLEEDING FROM THE OUTFLOW CANNULA IN THE AREA OF THE CONNECTOR. THE PATIENT WAS BROUGHT INTO ICU FOR A TRANSFUSION AND THE SHORTENING OF THE CANNULA. THE AFFECTED CANNULA WAS SHORTENED BY TRAINED SPECIALIST PERSONNEL IN THE CLINIC AND THE EXCOR BLOOD PUMP WAS REPLACED. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND LEFT THE ICU SHORTLY AFTER THE SHORTENING OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267435 ↗
• MalfunctionDec 10, 2019Material Puncture/Hole; Material Puncture/Hole

  BERLIN HEART INC. WAS INFORMED ABOUT AN INCIDENT INVOLVING THE APEX CANNULA OF AN EXCOR PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC REPORTED THAT THE APEX CANNULA WAS DISRUPTED DURING A PUMP EXCHANGE, RESULTING IN BLOOD LOSS. ADDITIONALLY, AIR ENTERED THE BLOOD PUMP AND THE AORTIC CANNULA. THE PATIENT WENT INTO CARDIAC ARREST. CPR WAS PERFORMED UNTIL THE NEW PUMP WAS PLACED ON AND NORMAL SINUS ACTIVITY WAS REGAINED. THE NEW PUMP WAS CONNECTED AND THE PUMP AND CANNULA DE-AIRED. THE PATIENT WAS TAKEN TO HAVE A HEAD CT WHICH REVEALED 2 LARGE FRONTAL LOBE ISCHEMIC EVENTS. THE PATIENT WAS DEEMED TO NO LONGER BE A TRANSPLANT CANDIDATE AND THE PARENTS WISHED TO WITHDRAW SUPPORT. ON 2019-11-19, THE CLINIC REPORTED THAT THE PATIENT WAS WITHDRAWN FROM SUPPORT AND THE PATIENT DIED ON (B)(6) 2019. THE AFFECTED CANNULA WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: Death

  MAUDE report 9446600 ↗
• MalfunctionDec 3, 2019Material Puncture/Hole; Material Puncture/Hole

  BERLIN HEART INC. WAS INFORMED ABOUT AN INCIDENT INVOLVING THE APEX CANNULA OF AN EXCOR PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC REPORTED A HOLE IN THE APEX CANNULA WITH ALARMING FROM THE IKUS "CHECK LEFT PUMP AND DRIVING TUBE". THE CLINIC BRIEFLY SWITCHED TO THE HAND PUMP AND THEN DECIDED TO CLAMP THE CANNULAE AND PERFORM A PUMP EXCHANGE. ON (B)(6) 2019, THE CLINIC REPORTED THAT THE PATIENT WAS CLINICALLY STABLE. THE AFFECTED BLOOD PUMP AND A PIECE OF THE AFFECTED CANNULA WAS RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION ON (B)(6) 2019. ON (B)(6) 2019, WE WERE INFORMED BY THE HOSPITAL THE PATIENT IS COMPLETELY BACK TO BASE LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404880 ↗

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
• 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