EXCOR® C22A-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04260090040492), received between Aug 31, 2021 and Oct 22, 2025 — classified as 2 deaths, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE SITE CONTACTED BERLIN HEART INC. ON 2025-09-30 TO REPORT THAT ON (B)(6) 2025 THERE HAD BEEN AN EVENT INVOLVING A CANNULA BREACH WITH THE PATIENT IDENTIFIED IN THIS REPORT. ACCORDING TO THE SITE, THE PATIENT WAS SITTING UP IN A HIGHCHAIR WHEN THE NURSE NOTICED A PINPOINT SIZED DROP OF BLOOD ON THE INFLOW EXCOR APEX CANNULA FOR CHILDREN Ø 12/9 MM; L 27 CM (LOT 00143453), JUST ABOVE THE TITANIUM STUB OF THE EXCOR CANNULA EXTENSION SET Ø 9/9 MM (LOT NO. 00149265). THE RN CLAMPED THE CANNULA. THE SITE FURTHER STATED THAT THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND SUCCESSFULLY EXPLANTED FROM THE EXCOR SYSTEM ON THE SAME DAY AS THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT AND HAS NO REPORTED NEUROLOGICAL DEFICITS. OF NOTE, THE PATIENT WAS ORIGINALLY PLANNED FOR EXPLANTATION IN THAT WEEK DUE TO RECOVERY OF HEART FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358196 ↗
• DeathAug 12, 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 2025-07-17 THAT A PATIENT SUFFERED AN HEMORRHAGIC STROKE AFTER RECEIVING FIBRINOLYTICS FOR A CLOT IN ONE OF THE CANNULAE. AS A RESULT, THE PATIENT WAS DECLARED BRAIN DEAD. CARE WAS WITHDRAWN FROM THE PATIENT ON (B)(6) 2025. THE PATIENT WAS BEING SUPPORTED WITH THE EXCOR SYSTEM IN BI-VAD CONFIGURATION. DEPOSITS WERE NOTED IN THE EXCOR CANNULAE.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 22786576 ↗
• MalfunctionMar 20, 2025Fracture; Fracture

  ON 2025-02-24, THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT AN ISSUE WITH THE EXCOR APEX CANNULA FOR CHILDREN Ø 12/9 MM; L 27 CM (LOT 00146674). THE SITE OBSERVED A CRACK AT THE PUMP-CANNULA CONNECTION. UPON EVALUATING THE PICTURES PROVIDED BY THE SITE, CA CONFIRMED THE PRESENCE OF THE CRACK AND ADVISED THE SITE TO REPLACE THE AFFECTED PART OF THE CANNULA IMMEDIATELY. THE SITE PERFORMED A PUMP CHANGE ON (B)(6)2025. THE AFFECTED PART OF THE CANNULA WAS ALSO CUT FROM THE CANNULA AND SENT TO BERLIN HEART ALONG WITH THE PUMP. DURING THE EVENT, THE PUMP MAINTAINED COMPLETE FILLING AND EJECTION, AND NO LEAKAGE FROM THE CANNULA WAS NOTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657644 ↗
• MalfunctionJan 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SITE CONTACTED CLINICAL AFFAIRS TO REPORT A CUT IN THE SILICONE PART AND VELOUR PART OF THE INFLOW CANNULA. IT RESULTED IN BLEEDING FROM THE APICAL CANNULA IN THE AREA OF DAMAGED CANNULA. THE BLOOD PUMP INCLUDING THE EXTENSION SET WAS REPLACED WITHOUT ANY PROBLEMS ON (B)(6) 2023. THE SITE REPORTED THAT THE DAMAGED PORTION OF THE CANNULA WAS CUT OFF PRIOR TO THE PUMP EXCHANGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16241022 ↗
• DeathJan 12, 2022Fracture; Fracture

  WE WERE INFORMED BY THE DISTRIBUTOR ON (B)(6) 2021 ABOUT A BREACH IN THE INFLOW CANNULA OF A PATIENT SUPPORTED WITH THE EXCOR PEDIATRIC IN THE LVAD CONFIGURATION. THE CLINIC REPORTED THE BREACH WAS FOUND IN THE CANNULA IN THE AREA OF THE BLOOD PUMP CONNECTOR. AIR WAS INTRODUCED INTO THE CANNULA AT THE SITE OF THE BREACH RESULTING IN AN AIR EMBOLISM TO THE PATIENT. THE PATIENT, WHO HAD BEEN SUPPORTED WITH THE EXCOR PEDIATRIC FOR 1108 DAYS DIED AS A RESULT OF THIS EVENT.

  Patient problems: Air Embolism

  MAUDE report 13236051 ↗
• MalfunctionJan 12, 2022Material Puncture/Hole; Material Puncture/Hole

  WE WERE INFORMED BY THE DISTRIBUTOR ABOUT A SMALL BREACH IN THE INFLOW CANNULA OF A PATIENT SUPPORTED WITH THE EXCOR PEDIATRIC IN THE LVAD CONFIGURATION. THE CLINIC REPORTED A SMALL AMOUNT OF BLOOD LEAKING FROM THE CANNULA IN THE AREA OF THE BLOOD PUMP CONNECTOR. THE CANNULA WAS DISCONNECTED FROM THE BLOOD PUMP AND THE PORTION OF THE CANNULA WHERE THE BLOOD WAS LEAKING WAS REMOVED AND THE BLOOD PUMP WAS EXCHANGED BY TRAINED SPECIALIST PERSONNEL IN THE CLINIC. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT. SHORTLY BEFORE THE DETECTION OF THE BREACH IN THE CANNULA, THE SITE REPORTED THAT THE PATIENT HAD AN EPILEPTIC SEIZURE AND FELL DOWN WHICH CAUSED SEVERE KINKING OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236042 ↗
• MalfunctionAug 31, 2021Fracture; Fracture

  THE SITE CONTACTED BERLIN HEART INC. ON (B)(6)2021 TO REPORT THAT A PATIENT BEING SUPPORTED WITH AN EXCOR BLOOD PUMP IN THE LVAD CONFIGURATION EXPERIENCED A MASSIVE BLEEDING EVENT ON (B)(6) 2021. THE SITE REPORTED THAT THE GRANDMOTHER RAISED THE PATIENT FROM A LYING TO A SITTING POSITION IN THE PATIENT´S BED AND NOTICED A SUDDEN APPEARANCE OF A LARGE AMOUNT OF BLOOD. THE MEDICAL TEAMS IMMEDIATELY CAME TO THE BEDSIDE BUT WERE NOT ABLE TO DETERMINE THE SOURCE OF THE BLEEDING. A CODE WAS CALLED AND THE PATIENT WAS VOLUME RESUSCITATED. THE ATTENDING PHYSICIAN TRIED TO HAND PUMP THE DEVICE WITH NO SUCCESS AS THE PATIENT HAD NOT ENOUGH INTRAVASCULAR VOLUME. THE EXCOR CANNULAS WERE CLAMPED OFF AND THE MEDICAL TEAM EMERGENTLY PLACED THE CHILD ON ECMO FOR VOLUME REPLACEMENT AND CIRCULATORY SUPPORT. WHEN ECMO WAS INITIATED, THE ATTENDING PHYSICIAN FOUND A BREACH IN THE ARTERIAL CANNULA AT THE JUNCTION TO THE CONNECTING SET. THE SITE REPORTED WHEN THEY CALLED ON (B)(6) 2021 THAT THE PATIENT WAS BEING SUPPORTED ON ECMO, WITH THE EXCOR BLOOD PUMP CANNULAS STILL CONNECTED TO THE PATIENT BUT CLAMPED OFF, BUT THAT THE EXSANGUINATION EVENT LED TO A SEVERE CEREBRAL AND INTESTINAL HYPOXIC INJURY, DOC

  Patient problems: Exsanguination

  MAUDE report 12391469 ↗

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