EXCOR® L20H-003x01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260090040577), received between Jan 24, 2019 and Jun 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2021Leak/Splash; Leak/Splash

  BERLIN HEART (B)(4) WAS INFORMED BY THE SITE VIA THE HOTLINE THAT A LEAKAGE WAS DETECTED IN THE DRIVING TUBE OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE DRIVING TUBE WAS EXCHANGED IN THE CLINIC. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913506 ↗
• MalfunctionJan 24, 2019Leak/Splash; Leak/Splash

  WE WERE INFORMED BY THE CLINIC THAT A LEAK WAS DETECTED IN THE DRIVING TUBE OF THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BIVAD CONFIGURATION. THE DRIVING TUBE WAS CHANGED WITHOUT INCIDENT BY EXPERIENCED PERSONNEL IN THE CLINIC. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE EXCHANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8275509 ↗

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