EXCOR® C19V-020mRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04260090041277), received between Nov 22, 2024 and Dec 4, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Scratched Material; Scratched Material

  ON (B)(6) 2025, THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT A PORTION OF THE EXCOR ATRIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM IN RVAD HAD BEEN EXCISED DUE TO AN EXTERNAL SCRATCH ON THE CANNULA, 4-5 MM BELOW THE VELOUR. ACCORDING TO THE SITE, THE CONCERNING PORTION OF THE CANNULA WAS EXCISED AND A NEW EXCOR EXTENSION SET; Ø 6/6 MM WAS PLACED. DUE TO THE LOCATION OF THE DEFECT, THE TITANIUM STUB OF THE EXTENSION SET IS UNDER THE VELOUR. THE SITE REPORTED THAT THE EXCISION AND EXTENSION PLACEMENT WENT WITHOUT INCIDENT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING AND EJECTION THROUGHOUT. THE SITE REPORTED THAT THE EXCISED PORTION OF THE CANNULA WAS DISCARDED AND THEREFORE WILL NOT BE RETURNED TO BHI FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715959 ↗
• MalfunctionDec 4, 2025Scratched Material; Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON 2025-11-18 TO REPORT AN EXTERNAL, PALPABLE, SCRATCH THAT WAS FOUND ON THE EXCOR ATRIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM RIGHT BELOW THE VELOUR. THE SITE PLANNED TO EXCISE THE AFFECTED AREA AND PLACE A NEW EXCOR EXTENSION SET; Ø 6/6 MM. ACCORDING TO THE SITE THE PATIENT CURRENTLY REMAINED HEMODYNAMICALLY STABLE THROUGHOUT, AND THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING AND EJECTION. THE PATIENT HAD NO HARM DUE TO THE EVENT. ON 2025-11-20, WHICH IS (2 DAYS) AFTER THE EVENT, THE SITE NOTIFIED BHI CA THAT THE AFFECTED PORTION OF THE CANNULA WAS EXCISED, AND A 6-6 EXTENSION SET WAS PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715754 ↗
• MalfunctionNov 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON 2025-11-05 BERLIN HEART INC. CLINICAL AFFAIRS (CA) WAS NOTIFIED THROUGH THE ACTION DATABASE THAT ON (B)(6) 2025, THE INFLOW EXCOR ATRIAL CANNULA FOR SMALL CHILDREN Ø 6 MM, ON PATIENT WAS TRIMMED DUE TO FATIGUED TUBING AT THE TITANIUM CONNECTION. ACCORDING TO THE SITE CONTACT, THE AFFECTED PORTION OF THE CANNULA WAS CUT AND DISCARDED, AND THE BLOOD PUMP WAS SUCCESSFULLY RE-CONNECTED WITHOUT ADVERSE EFFECTS TO THE PATIENT. PRIOR TO THE EXCHANGE, THE BLOOD PUMP DEMONSTRATED COMPLETE FILLING AND EJECTION, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. ALTHOUGH THIS EVENT HAD NO NEGATIVE EFFECT ON THE PATIENT, THIS KIND OF DEFECT COULD POTENTIALLY RESULT IN A DISRUPTION 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 23632993 ↗
• MalfunctionNov 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 2024-11-12, THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT A CUT IN THE INFLOW ATRIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM; HEAD 14 MM (LOT NO. 00126464) CANNULA OF THE RVAD IN A BVAD CONFIGURATION. THE SITE NOTICED THE CUT DURING A ROUTINE PUMP ASSESSMENT AND DEPOSIT CHECK. THE SITE REMOVED THE DEFECTIVE PART AND REPLACED IT WITH AN EXTENSION SET. CA REQUESTED THE RETURN OF THE DEFECTIVE PART FOR FURTHER INVESTIGATION. DURING THE EVENT, BOTH PUMPS MAINTAINED COMPLETE FILL AND EJECTION, AND THE PATIENT WAS ADEQUATELY SUPPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792800 ↗
• MalfunctionNov 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 2024-11-07 THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT A CUT ON THE INFLOW ATRIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM; HEAD 14 MM (LOT NO. 00126464) OF THE RVAD CANNULA IN THE BVAD CONFIGURATION. THEY NOTICED THE CUT DURING A ROUTINE PUMP ASSESSMENT AND DEPOSIT CHECK. THE SITE ALSO REPORTED THAT TOUCHING ALONG THE CUT REVEALED A VISIBLE GAP THAT LOOKED LIKE A DEEP CUT. CA REQUESTED PICTURES OF THE INFLOW CANNULA FOR FURTHER ASSESSMENT. CA CONFIRMED THE CUT IN THE PICTURES AND RECOMMENDED AN IMMEDIATE REPLACEMENT OF THE DEFECTIVE PART DUE TO THE HIGH RISK OF CANNULA DISRUPTION. ON 2024-11-07, THE SITE REMOVED THE DEFECTIVE PART OF THE CANNULA AND REPLACED IT WITH AN EXTENSION SET. CA REQUESTED THE RETURN OF THE DEFECTIVE PART FOR FURTHER INVESTIGATION. DURING THE EVENT, BOTH PUMPS MAINTAINED COMPLETE FILL AND EJECTION, AND THE PATIENT WAS ADEQUATELY SUPPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761728 ↗

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