EXCOR® C80G-040mRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260090041369), received between Mar 28, 2024 and Mar 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Fracture; Fracture

  BERLIN HEART GMBH WAS INFORMED BY THE CLINIC THAT A CANNULA BREACH ON A PATIENT SUPPORTED IN LVAD CONFIGURATION ON THE EXCOR ACTIVE DRIVER. THE BREACH OCCURRED ON THE OUTFLOW CANNULA AT THE JUNCTION OF SILICONE AND VELOUR.THE VAD WAS DISCONNECTED AND CPR PERFORMED. CPR WAS EFFECTIVE AND THE PATIENT WAS PLACED ON ECMO. ON (B)(6) 2024 THE PATIENT WAS CONVERTED BACK TO A BERLIN HEART EXCOR PUMP. THE CT RESULT SHOWED THAT THE PATIENT'S BRAIN AND OTHER ORGANS ARE FUNCTIONING NORMAL AND THE PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000612 ↗

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