EXCOR® L20H-002x01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04260090040560), received between Mar 31, 2016 and Mar 3, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Fracture

  ON 2026-02-09, BERLIN HEART CLINICAL AFFAIRS WAS INFORMED BY THE JAPANESE DISTRIBUTOR THAT THE CLINIC NOTED A CRACK IN THE EXCOR DRIVING TUBE L20H-002X01 AND THE DRIVING TUBE WAS EXCHANGED WITHOUT ANY COMPLICATIONS. THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT. THE PATIENT HAD NO HARM AND NO CHANGE IN CLINICAL STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24502220 ↗
• MalfunctionJul 2, 2025Gas/Air Leak; Gas/Air Leak

  ON (B)(6) 2025 THE CLINIC CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS TO REPORT THAT THE EXCOR DRIVING TUBE L20H-002X01 WAS CHANGED DUE TO AN AUDIBLE AND PALPABLE AIR LEAK. ACCORDING TO THE SITE, THE AIR LEAK WAS NOTED IN THE DRIVING TUBE AROUND THE AREA WHERE IT CONNECTED TO THE BLOOD PUMP. THE CABLE TIE WAS NOTED TO BE SECURE AND IN THE PROPER POSITIONING. A REVIEW OF LOG FILES REVEALED SEVERAL H1: PRESSURE LOSS ALARMS ON THE EXCOR ACTIVE DRIVING UNIT AT THE TIME OF EVENT. THESE ALARMS WERE MUTED BY THE USER. THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT. THE AFFECTED DRIVING TUBE WAS CHANGED, AND THE PATIENT TOLERATED THE DRIVING TUBE CHANGE WITH NO SIGNIFICANT CLINICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385313 ↗
• MalfunctionJun 19, 2025Gas/Air Leak; Gas/Air Leak

  ON 2025-05-30, THE CLINIC CONTACTED BERLIN HEART GMBH AFFAIRS TO REPORT AN INCIDENT WITH THE EXCOR DRIVING TUBE L20H-002X01 ON A PATIENT SUPPORTED WITH AN EXCOR ACTIVE DRIVING UNIT. THE CLINIC STATED THAT ON (B)(6) 2025, THE EXCOR ACTIVE EMITTED AN H1 PRESSURE LOSS ALARM, AND A CRACK IN THE DRIVING TUBE WAS IDENTIFIED BY THE CLINIC PERSONNEL. THE AFFECTED DRIVING TUBE WAS REPLACED IMMEDIATELY WITHOUT ANY PROBLEMS. THE PATIENT REMAINED STABLE THROUGHOUT, AND NO NEGATIVE EFFECTS WERE REPORTED. THE PATIENT WAS SUCCESSFULLY TRANSPLANTED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293799 ↗
• MalfunctionFeb 20, 2025Gas/Air Leak; Gas/Air Leak

  ON (B)(6)2025 THE CLINIC REPORTED H1: PRESSURE LOSS" ALARM, INSUFFICIENT AIR BALANCING VALVE OPENINGS, WITH NO RESPONSE IN DRIVING PRESSURE TRIGGERED BY THE EXCOR ACTIVE DRIVER. BERLIN HEART RECOMMENDED A DRIVER EXCHANGE. HOWEVER, ON (B)(6)2025., THE SITE SWITCHED TO A BACKUP DRIVER AND REPLACED THE DRIVING TUBE WITHOUT INFORMING BERLIN HEART CLINICAL AFFAIRS AND RETURNED THE PREVIOUS DRIVING TUBE TO THE MANUFACTURER. BASED ON THE LOG FILES OF THE NEW DRIVER, NO FURTHER H1 ALARMS WERE OBSERVED AFTER REPLACING THE DRIVER AND THE DRIVING TUBE. THE PATIENT REMAINED STABLE, AND NO NEGATIVE EFFECTS WERE REPORTED. ON (B)(6)2025, BERLIN HEART RECEIVED THE USED EXCOR DRIVING TUBE L20H-002X01 FROM THE CLINIC. THE RETURNED DRIVING TUBE IS SUSPECTED TO HAVE AN ISSUE WITH LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426602 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  THE SITE CONTACTED BERLIN HEART (BHI) CLINICAL AFFAIRS (CA) TO INFORM THAT ON (B)(6) 2024 THE DRIVING TUBE WAS CHANGED DUE TO A CRACK IN THE TUBE. ACCORDING TO THE SITE, THE PUMP MAINTAINED COMPLETE FILL AND EJECTION, AND THE PATIENT TOLERATED THE PROCEDURE WELL. HOWEVER, THE DRIVING TUBE WAS EXCHANGED WITHOUT PRIOR CONSULTATION FROM BHI CA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305557 ↗
• MalfunctionMar 6, 2024Gas/Air Leak; Gas/Air Leak

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) TO INFORM THAT AT AROUND 2;00 AM, THE BEDSIDE NURSE HEARD A HISSING NOISE COMING FROM THE DRIVELINE AND CRACK WAS FOUND NEAR THE CONNECTION AT THE PUMP.THE CRACK WAS TEMPORARILY REINFORCED BY PLACING A TAPE AROUND THE CRACK. ACCORDING TO THE SITE, THE PUMP MAINTAINED COMPLETE FILL AND EJECTION, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE DRIVE LINE WAS EXCHANGED WITHOUT ANY INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18850976 ↗
• InjuryDec 4, 2023Gas/Air Leak; Gas/Air Leak

  BERLIN HEART INC. WAS INFORMED BY THE CLINIC VIA HOTLINE THAT A LEAK WAS DETECTED IN THE DRIVING TUBE OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE PUMP FUNCTION WAS NOT AFFECTED WITH COMPLETE EMPTYING AND FILLING. THE DRIVING TUBE WAS CHANGED WITHOUT INCIDENT. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE EXCHANGE AND IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259929 ↗
• MalfunctionDec 4, 2023Gas/Air Leak; Gas/Air Leak

  BERLIN HEART INC. WAS INFORMED BY THE CLINIC VIA HOTLINE THAT A LEAK WAS DETECTED IN THE DRIVING TUBE OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE PUMP FUNCTION WAS NOT AFFECTED WITH COMPLETE EMPTYING AND FILLING. THE DRIVING TUBE WAS CHANGED WITHOUT INCIDENT. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE EXCHANGE AND IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259804 ↗
• MalfunctionNov 9, 2021Leak/Splash; Leak/Splash

  BERLIN HEART (B)(4) WAS INFORMED BY THE CLINIC THAT A LEAKAGE WAS DETECTED IN THE DRIVING TUBE OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE DRIVING TUBE WAS EXCHANGED IN THE CLINIC. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE EXCHANGE AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781121 ↗
• MalfunctionApr 11, 2021Leak/Splash; Leak/Splash

  BERLIN HEART (B)(4) WAS INFORMED BY THE CLINIC VIA THE HOTLINE THAT A CRACK WAS DETECTED IN THE DRIVING TUBE NEAR THE DRIVING TUBE PORT OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. CONFIGURATION. THE PUMP FUNCTION WAS NOT AFFECTED. THE PUMP CONTINUED TO PERFORM AS INTENDED WITH COMPLETE FILL AND EJECTION. THE DRIVING TUBE WAS EXCHANGED WITHOUT INCIDENT BY EXPERIENCED PERSONNEL IN THE CLINIC. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE EXCHANGE AND IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646907 ↗
• MalfunctionFeb 15, 2019Leak/Splash; Leak/Splash

  BERLIN HEART INC. WAS INFORMED BY THE CLINIC VIA HOTLINE THAT A CRACK WAS DETECTED IN THE DRIVING TUBE OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE PATIENT WAS STABLE AND THE CRACK WAS REINFORCED BY THE CLINIC. THE PUMP FUNCTION WAS NOT AFFECTED WITH COMPLETE EMPTYING AND FILLING. THE DRIVING TUBE WAS CHANGED WITHOUT INCIDENT BY EXPERIENCED PERSONNEL IN THE CLINIC. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE EXCHANGE AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343751 ↗
• MalfunctionJul 20, 2018Leak/Splash; Leak/Splash

  WE WERE INFORMED BY OUR (B)(4) DISTRIBUTOR THAT THE CLINIC DETECTED A SMALL LEAK AT THE TRANSITION POINT FROM THE SMALLER TO LARGER DIAMETER OF THE DRIVING TUBE. THE DRIVING TUBE WAS CHANGED WITHOUT INCIDENT BY EXPERIENCED PERSONNEL IN THE CLINIC. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE EXCHANGE WELL WITH NO UNTOWARD EFFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707605 ↗
• MalfunctionDec 19, 2017Air Leak; Air Leak

  WE WERE INFORMED BY OUR (B)(4) DISTRIBUTOR THAT FLOW ALARMS WERE NOTED IN A PATIENT SUPPORTED IN LVAD CONFIGURATION. UPON INSPECTION, THE CLINIC DETECTED A DEFECT IN THE RED DRIVING TUBE AT THE TRANSITION POINT FROM THE SMALLER TO LARGER DIAMETER OF THE DRIVING TUBE. THE DRIVING TUBE WAS CHANGED ON (B)(6) 2017 WITHOUT INCIDENT BY EXPERIENCED PERSONNEL IN THE CLINIC. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE DRIVING TUBE EXCHANGE WELL WITH NO UNTOWARD EFFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129319 ↗
• MalfunctionJun 7, 2017Air Leak; Air Leak

  BERLIN HEART WAS INFORMED BY OUR (B)(4) DISTRIBUTOR THAT A DEFECT WAS OBSERVED IN THE RED DRIVING TUBE OF AN EXCOR BLOOD PUMP ON A PATIENT SUPPORTED IN LVAD CONFIGURATION. THE CLINIC PROVIDED BERLIN HEART WITH PICTURES AND VIDEO MATERIAL. UPON REVIEWING THE PICTURES AND THE VIDEO, IT WAS OBSERVED THERE WAS A SMALL BREAK IN THE DRIVE LINE, NEAR THE TRANSITION FROM THE THICKER TO THE THINNER SEGMENT. CA SUGGESTED TO CHANGE THE DRIVE LINE. THE DRIVE LINE WAS CHANGED WITHOUT INCIDENT BY EXPERIENCED PERSONNEL IN THE CLINIC. ACCORDING TO THE CLINIC, THE PUMP FUNCTION WAS NOT AFFECTED BY THIS EVENT. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE DRIVE LINE EXCHANGE WELL WITH NO UNTOWARD EFFECT. WE WERE INFORMED THAT THE PATIENT WAS SUCCESSFULLY TRANSPLANTED ON (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6618813 ↗
• MalfunctionMar 31, 2016Air Leak; Air Leak

  THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) TO INFORM THAT THEY HEARD A HISSING NOISE COMING FROM THE DRIVE LINE. CA SUGGESTED TO CHANGE THE DRIVE LINE. THE DRIVE LINE WAS CHANGED WITHOUT INCIDENT. THE SITE REPORTED THAT AFTER THE DRIVE LINE CHANGE THE HISSING NOISE STOPPED AND SMALL CRACK WAS FOUND IN THE OLD DRIVING TUBE NEAR THE CONNECTION AT THE PUMP. THE PUMP WAS FULLY FILLING AND EJECTING THROUGHOUT THE EVENT AND THERE WAS NO UNTOWARD EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5537701 ↗

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