EXCOR® C19V-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260090040461), received between Dec 15, 2022 and Dec 15, 2022 — 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 (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Fracture; Fracture

  LOG. THE SITE CONTACTED CLINICAL AFFAIRS AND REPORTED THE INFLOW CANNULA TO THE RIGHT PUMP WAS LEAKING BLOOD. PER THE SITE, IT WAS DRIPPING BLOOD AT THE TITANIUM CONNECTOR TO THE INFLOW OF THE RIGHT PUMP AND A TEGADERM DRESSING WAS APPLIED TO STOP THE LEAK. THE SITE WAS INSTRUCTED TO REMOVE THE DRIVE TUBE FROM THE IKUS AND CLAMP THE CANNULA. BY REPORT FROM THE SITE, UPON ARRIVAL TO THE OR, THE PATIENT BECAME AGITATED, ROLLED IN BED CAUSING EXTENSION OF THE DISRUPTION OF THE CANNULA, MORE BLEEDING WAS NOTED AND AIR ENTRAINED INTO THE PUMP. THE CANNULAS WERE THEN CLAMPED AND THE PATIENT WAS EMERGENTLY TRANSITIONED TO AN ECMO THAT WAS CONNECTED TO THE BH CANNULAS ON THE RIGHT SIDE. AFTER THE ECMO TRANSITION, THE PATIENT WAS TAKEN TO CT. CT RESULTS SHOWED GLOBAL ISCHEMIA WITH A MASSIVE AIR EMBOLISM IN THE VENOUS SYSTEM. FAMILY ELECTED TO WITHDRAW CARE AT THIS TIME.

  Patient problems: Air Embolism

  MAUDE report 15992031 ↗

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