EXCOR® D03I-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04260090040225), received between Mar 31, 2016 and Jun 15, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2025Output Problem; Output Problem

  ON 2025-05-17 THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS TO REPORT THAT AN EXCOR IKUS DRIVING UNIT CHANGE OCCURRED. ACCORDING TO THE SITE REPORT, THE IKUS DRIVING UNIT WAS IN USE ON A PATIENT SUPPORTED WITH A 10 ML EXCOR BLOOD PUMP, WHEN THE DRIVER BEGAN AUDIBLY ALARMING CONTINUOUSLY AND DISPLAYED A LOGIN ERROR. THE SITE REPORTED THAT THE BLOOD PUMP MEMBRANE STOPPED MOVING DURING THE EVENT. THE SITE ALSO REPORTED THAT THEY HAND PUMPED THE PATIENT WHILE THE AFFECTED IKUS DRIVING UNIT WAS SWITCHED TO THE BACKUP UNIT. ONCE THE BACKUP DRIVING UNIT WAS CONNECTED, THE PUMP MEMBRANE RESUMED MOVEMENT AS INTENDED. THE PATIENT WAS STABLE THROUGHOUT. BHI CA WAS NOTIFIED AFTER THE EVENT, AND THE AFFECTED IKUS DRIVER WAS COLLECTED AS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208645 ↗
• MalfunctionJan 17, 2025Output Problem; Output Problem

  THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS TO REPORT THAT THE PATIENT SUPPORTED WITH BERLIN HEART IKUS STATIONARY DRIVING UNIT AND WITH 10 ML EXCOR BLOOD PUMPS ON A BVAD CONFIGURATION SHOWED INCOMPLETE FILL IN BOTH OF THE PUMPS, MORE FREQUENTLY IN THE LEFT PUMP THAN THE RIGHT PUMP. DURING THE EVENT, SEVERAL ALARMS WERE EMITTED BY THE IKUS DRIVER. DURING THE "CHECK LEFT PUMP" ALARM, THE VAD SYSTEM HAD "LITTLE TO NO FILL OR EJECT" WITH EACH PUMP, HOWEVER, IT WAS STILL PUMPING. IT WAS NOTED HOWEVER, THAT THE FILL WAS MARKEDLY LESS/INSUFFICIENT WHEN COMPARED TO ITS PERFORMANCE BEFORE THE ALARM. THE HAND PUMP WAS NOT USED. THE IKUS DRIVER IN QUESTION WAS TURNED OFF WITHOUT RETRIEVING LOG FILES AND SWITCHED OUT WITH A BACK-UP DRIVER. THE DRIVER EXCHANGE WENT UNEVENTFUL, AND THE PUMPS WERE FILLING AND EJECTING COMPLETELY. THE PATIENT REMAINED STABLE, AND NO SIGNIFICANT CLINICAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183172 ↗
• MalfunctionFeb 12, 2024Output Problem; Output Problem

  BERLIN HEART INC. CLINICAL AFFAIRS RECEIVED A CALL FROM A PHYSICIAN AT THE HOSPITAL REQUESTING ASSISTANCE IN TROUBLESHOOTING INCOMPLETE EJECTION FROM THE EXCOR BLOOD PUMP ON A PATIENT SUPPORTED WITH EXCOR VAD SYSTEM, WHO HAS A 9MM INFLOW CANNULA AND 6MM OUTFLOW CANNULA WITH A 25ML EXCOR BLOOD PUMP. THE PHYSICIAN STATED THAT EARLIER IN THE EVENING IT WAS NOTED THAT THE BLOOD PUMP HAD INCOMPLETE EJECTION IN WHICH THE TEAM ADJUSTED THE PARAMETER SETTINGS ON THE IKUS DRIVER AND ADMINISTERED AFTERLOAD REDUCTION TO THE PATIENT, BUT STILL THE PUMP CONTINUED TO HAVE INCOMPLETE EJECTION. THE PHYSICIAN ALSO STATED THAT THE WAVE FORM ON THE IKUS HAD CHANGED FROM NORMAL PRESSURE GRAPH. CA AGREED WITH THE PHYSICIAN TO GET A CT SCAN TO CHECK CANNULA PLACEMENT AND FOR OUTFLOW OBSTRUCTION. CA WAS CONTACTED AGAIN FOLLOWING THE CT SCAN, AND INFORMED WHEN MOVING THE PATIENT BACK INTO THE BED FROM THE CT SCANNER, THEY NOTED THAT THE WAVEFORM ON THE IKUS WENT BACK TO NORMAL, AND THE PUMP IMMEDIATELY BEGAN EJECTING COMPLETELY. THE WAVEFORM HAS BEEN NORMAL, AND PUMP IS COMPLETELY INJECTING EVER SINCE. THROUGHOUT THE EVENT THERE WERE NO ALARMS FROM THE IKUS. PICTURES OF THE IKUS WAVEFORMS DURING AND AFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689246 ↗
• MalfunctionDec 9, 2022Output Problem; Output Problem

  SITE REPORTED ABNORMAL LVAD WAVEFORM ON IKUS LAPTOP ALONG WITH INCOMPLETE EJECTION OF BLOOD PUMP. BLOOD PUMP MAINTAINED COMPLETE FILLING. PATIENT REMAINED ACTIVE/ENERGETIC AND WAS HEMODYNAMICALLY STABLE WITH BIVALARUDIN DRIP. SITE STATED THAT NO SIGNS OF BLOOD MEMBRANE RUPTURE. NO "SQUEAKING OR CRUNCHING" SOUNDS EMITTED FROM THE BLOOD PUMP. BERLIN HEART RECOMMENDED INCREASING LVAD SYSTOLIC PRESSURE. SITE REPORTED THAT EJECTION WAS SOMEWHAT IMPROVED WITH INCREASE IN SYSTOLIC PRESSURE AND THEY WOULD CONTINUE TO INCREASE AS APPROPRIATE. SITE REPORTED THE NEXT DAY THAT THE PATIENT CONTINUED WITH INCOMPLETE EJECTION. THE LOG FILES WERE REVIEWED BY A BERLIN HEART INC. SERVICE ENGINEER WHO RECOMMEND THE IKUS BE RETURNED FOR INVESTIGATION. THE IKUS WAS SWITCHED TO BACK-UP DEVICE WITHOUT EVENT. THE BLOOD PUMP IMMEDIATELY RESUMED COMPLETED FILLING AND EJECTION. PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT AND THE PATIENT CONTINUED TO BE AWAKE/ALERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955134 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE INITIALLY CONTACTED CLINICAL AFFAIRS (CA) TO REPORT THAT THE" PUMP STOPPED WORKING", AND THE PATIENT WAS BEING SUPPORTED USING THE HAND PUMP. CA HEARD THAT THE IKUS WAS AUDIBLY ALARMING IN THE BACKGROUND. THE SITE COULD NOT SPECIFY IF THE BLOOD PUMP OR THE IKUS UNIT HAD STOPPED WORKING. PER THE SITE, THE PATIENT WAS RECEIVING CPR WHILE BEING HAND PUMPED; HOWEVER, THE SITE CALLER WAS UNABLE TO VERIFY IF THE BLOOD PUMP WAS ACHIEVING COMPLETE FILL AND EJECTION DURING HAND PUMPING. PRIOR TO INITIATION OF HAND PUMPING AND CPR, THE NURSE ENTERED THE PATIENT'S ROOM AND NOTED THE PATIENT WAS "POSTURING, SEIZING AND RIGID," AND THUS, A CODE WAS CALLED. THE PATIENT WAS SUPPORTED VIA HAND PUMP FOR APPROXIMATELY 10-15 MINUTES, WHILE THE BACKUP IKUS WAS PREPARED. THE BACKUP IKUS WAS PROGRAMMED TO THE PATIENTS' CURRENT VAD SETTINGS AND CONNECTED TO THE PATIENT. THE SITE REPORTED THAT, ONCE THE BACKUP IKUS WAS CONNECTED TO THE PATIENT, THE BLOOD PUMP WAS FUNCTIONING AS EXPECTED WITH FULL FILL AND FULL EJECTION. THE IKUS UNIT IN QUESTION WAS RESTARTED TO COLLECT THE LOG FILES WHICH WERE DOWNLOADED AND SENT TO BHI FOR REVIEW BY THE SERVICE ENGINEERS. OF NOTE, PRIOR TO DOWNLOADING THE LOG F

  Patient problems: Ischemia

  MAUDE report 15465402 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE INITIALLY CONTACTED CLINICAL AFFAIRS (CA) TO REPORT THAT THE" PUMP STOPPED WORKING", AND THE PATIENT WAS BEING SUPPORTED USING THE HAND PUMP. CA HEARD THAT THE IKUS WAS AUDIBLY ALARMING IN THE BACKGROUND. THE SITE COULD NOT SPECIFY IF THE BLOOD PUMP OR THE IKUS UNIT HAD STOPPED WORKING. PER THE SITE, THE PATIENT WAS RECEIVING CPR WHILE BEING HAND PUMPED; HOWEVER, THE SITE CALLER WAS UNABLE TO VERIFY IF THE BLOOD PUMP WAS ACHIEVING COMPLETE FILL AND EJECTION DURING HAND PUMPING. PRIOR TO INITIATION OF HAND PUMPING AND CPR, THE NURSE ENTERED THE PATIENT'S ROOM AND NOTED THE PATIENT WAS "POSTURING, SEIZING AND RIGID," AND THUS, A CODE WAS CALLED. THE PATIENT WAS SUPPORTED VIA HAND PUMP FOR APPROXIMATELY 10-15 MINUTES, WHILE THE BACKUP IKUS WAS PREPARED. THE BACKUP IKUS WAS PROGRAMMED TO THE PATIENTS' CURRENT VAD SETTINGS AND CONNECTED TO THE PATIENT. THE SITE REPORTED THAT, ONCE THE BACKUP IKUS WAS CONNECTED TO THE PATIENT, THE BLOOD PUMP WAS FUNCTIONING AS EXPECTED WITH FULL FILL AND FULL EJECTION. THE IKUS UNIT IN QUESTION WAS RESTARTED TO COLLECT THE LOG FILES WHICH WERE DOWNLOADED AND SENT TO BHI FOR REVIEW BY THE SERVICE ENGINEERS. OF NOTE, PRIOR TO DOWNLOADING THE LOG F

  Patient problems: Ischemia

  MAUDE report 15465371 ↗
• MalfunctionJun 20, 2022Defective Device; Defective Device

  THE SITE CONTACTED BERLIN HEART, INC. CLINICAL AFFAIRS ON (B)(6) 2022 TO REPORT THAT THE LAPTOP ASSOCIATED WITH IKUS DRIVING UNIT IN QUESTION FROZE WHEN THE "ENTER" KEY WAS PRESSED TO ACKNOWLEDGE AN ENTRY. INCIDENTALLY, THE SITE WAS TRANSITIONING A CANNULA-ONLY IMPLANT FROM A CONTINUOUS FLOW DEVICE TO A BERLIN HEART SYSTEM. THE IKUS DRIVING UNIT HAD PASSED THE SELF-TEST AND COMPLETED THE TWO-HOUR WARM UP PERIOD WITHOUT ISSUES. THE SITE REPORTED THAT THE "ENTER" KEY COULD NOT BE PUSHED AGAIN, AND THAT THE LAPTOP SCREEN WAS MULTICHROMATIC WITH MULTIPLE SCREEN IMAGES SUPERIMPOSED OVER ONE ANOTHER. THE SITE STATED THE HAND PUMP WAS UTILIZED TO SUPPORT THE PATIENT UNTIL THE BACKUP IKUS DRIVING UNIT WAS READY TO BE USED. THE PATIENT REMAINED STABLE THROUGHOUT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744348 ↗
• MalfunctionSep 30, 2021Pumping Stopped; Pumping Stopped

  BERLIN HEART INC. WAS INFORMED BY THE SITE THAT THE IKUS NOTED ABOVE WAS IN USE ON A PATIENT SUPPORTED IN A BVAD CONFIGURATION. THE IKUS ALARMED "CHECK RIGHT PUMP AND DRIVING TUBE!". WHEN THE PHYSICIAN ENTERED THE PATIENT ROOM TO ASSESS THE SITUATION, SHE REPORTED THAT THE MEMBRANE OF THE RVAD BLOOD PUMP WAS IN THE END DIASTOLIC POSITION AND DID NOT MOVE FOR A PERIOD OF 2 MINUTES. THE SAME ALARM OCCURRED SEVERAL TIMES DURING THAT 2-MINUTE PERIOD BUT NO OTHER TYPE OF ALARMS OCCURRED. THE PHYSICIAN VERIFIED THAT THERE WERE NO KINKS IN THE CANNULAS OR DRIVING TUBE. THE IKUS CONTINUED TO FUNCTION AS EXPECTED AND THE LVAD PUMP HAD COMPLETE FILL AND EJECTION. THE PATIENT REMAINED CLINICALLY STABLE. THE RVAD BLOOD PUMP SPONTANEOUSLY RESTARTED WITHOUT ANY INTERVENTION. THE SITE EXCHANGED THE DRIVING UNIT TO THE BACKUP IKUS WITHOUT ANY UNTOWARD EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556213 ↗
• MalfunctionSep 14, 2021Pumping Stopped; Pumping Stopped

  BERLIN HEART INC. WAS INFORMED BY THE SITE ABOUT AN ISSUE WITH THE STATIONARY DRIVING UNIT IKUS OF A PATIENT SUPPORTED WITH THE EXCOR SYSTEM. THE SITE REPORTED THAT THE BLOOD PUMP HAD PAUSED FOR ONE MINUTE. THE PATIENT REMAINED CLINICALLY STABLE. THE IKUS WAS ALARMING "CHECK LEFT PUMP AND LEFT DRIVELINE." AFTERWARD, THE PUMP RESTARTED. THE BEDSIDE NURSE AT THE SITE ALSO REPORTED THERE WERE NO KINKS OF EITHER THE CANNULA OR DRIVELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469591 ↗
• MalfunctionNov 18, 2020Intermittent Loss of Power; Intermittent Loss of Power

  BERLIN HEART INC. WAS INFORMED BY THE CLINIC ABOUT AN ISSUE WITH THE STATIONARY DRIVING UNIT IKUS OF A PATIENT SUPPORTED WITH THE EXCOR SYSTEM. THE CLINIC REPORTED THAT THE IKUS LAPTOP HAD FROZEN. UPON RESTART THE LAPTOP, THE IKUS SETTINGS HAD CHANGED BACK TO ORIGINAL SETTINGS. THE CLINIC THEN READJUSTED THE PARAMETERS AND FOUND THAT THE WAVEFORM ON THE IKUS DID NOT MATCH THE SETTINGS. THE CLINIC ATTEMPTED TO CHANGE THE IKUS SETTINGS A FEW TIMES WITH NO CHANGE IN THE WAVE FORM. THE CLINIC REPORTED THAT THEY COULD NOT GET THE PUMP TO FILL COMPLETELY. BERLIN HEART RECOMMENDED THE EXCHANGE OF THE IKUS. TRAINED PERSONNEL AT THE CLINIC SWITCHED TO A BACK-UP IKUS DRIVING UNIT WITHOUT INCIDENCE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT AND IS DOING WELL. THE CLINIC SENT LOG FILES TO BERLIN HEART INC FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10861742 ↗
• MalfunctionApr 15, 2019Intermittent Loss of Power; Intermittent Loss of Power

  BERLIN HEART INC. WAS INFORMED BY THE CLINIC ABOUT AN ISSUE WITH THE STATIONARY DRIVING UNIT IKUS OF A PATIENT SUPPORTED WITH THE EXCOR SYSTEM. THE CLINIC REPORTED THAT THE IKUS WAS INTERMITTENTLY STOPPING AND ALARMING. THE DRIVELINE DID NOT HAVE ANY LEAKS AND APPEARED TO BE CONNECTED PROPERLY. THE CLINIC SENT LOG FILES TO BERLIN HEART INC FOR FURTHER INVESTIGATION. TRAINED PERSONNEL AT THE CLINIC SWITCHED TO A BACK-UP IKUS DRIVING UNIT WITHOUT INCIDENCE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516380 ↗
• MalfunctionOct 2, 2017Battery Problem; Battery Problem

  BERLIN HEART INC. CLINICAL AFFAIRS (CA) RECEIVED A CALL ON (B)(4) 2017 TO REPORT THAT IKUS DRIVER THAT WAS BEING USED ON A PATIENT SUPPORTED IN LVAD CONFIGURATION PRODUCED AN ERROR MESSAGE "BATTERIES DISCHARGED ALARM" WHILE ON BATTERY POWER ONLY FOR 10 MINUTES. THE NURSE REPORTED THAT THE MEMBRANE OF THE EXCOR BLOOD PUMP WAS NOT MOVING AND IKUS DID NOT APPEAR TO BE FUNCTIONING. THE NURSE SUPPORTED PATIENT USING THE HAND PUMP FOR SHORT PERIOD. THE IKUS WAS PLUGGED BACK IN TO MAINS POWER AND BEGAN TO FUNCTION AND RESUMED SUPPORTING THE PATIENT. THE SITE WAS ADVISED BY CA NOT TO UNPLUG THE IKUS UNIT AND REMAIN ON MAINS POWER UNTIL ABLE TO SWITCH TO A BACKUP UNIT AND THE IKUS WAS REPLACED WITHOUT AN INCIDENT. THE PATIENT SUFFERED NO UNTOWARD EFFECT DUE TO THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906738 ↗
• MalfunctionMar 10, 2017Device Inoperable; Device Inoperable

  THE MANUFACTURER, BERLIN HEART (B)(4), WAS INFORMED BY THE (B)(4) DISTRIBUTOR THAT A PROBLEM OCCURRED WITH THE STATIONARY DRIVING UNIT, IKUS OF AN EXCOR VAD PATIENT IN (B)(6). THE PATIENT RETURNED TO THE HOSPITAL ROOM AND THE IKUS WAS CONNECTED TO THE MAIN POWER SUPPLY. 20 MINUTES LATER, THE PATIENT COMPLAINED OF A HEADACHE AND SOON AFTER, LOST CONSCIOUSNESS. THE CLINICAL STAFF EXAMINED THE BLOOD PUMP AND COULD NOT DETECT ANY MOVEMENT OF THE MEMBRANE. NO ACOUSTIC ALARMS OR ABNORMALITIES WERE DISPLAYED ON THE MONITOR OF THE IKUS. THE PATIENT PRESENTED WITH CYANOTIC LIPS INDICATING REDUCED SUPPORT.THE HAND PUMP WAS USED TO SUPPORT THE PATIENT UNTIL TRANSFERRED TO THE BACK-UP IKUS ON SITE. THE PATIENT CONDITION IMPROVED FOLLOWING A FEW STROKES WITH THE HAND PUMP. AFTER 5 MINUTES, THE PATIENT WAS PLACED ON THE BACK-UP IKUS. PATIENT CONDITION QUICKLY IMPROVED FOLLOWING THE TRANSFER TO THE BACK-UP DEVICE. THE PATIENT DID NOT SUFFER IRREVERSIBLE DAMAGE DURING THIS EVENT AND IS CURRENTLY DOING WELL AGAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6396937 ↗
• MalfunctionMar 31, 2016Pumping Stopped; Pumping Stopped

  BERLIN HEART INC. CLINICAL AFFAIRS (CA) RECEIVED A CALL ON 3/6/2016 THAT THE IKUS MENTIONED ABOVE PRODUCED AN ERROR MESSAGE "BATTERIES DEPLETED, PLEASE CONNECT TO MAINS POWER SUPPLY" WHILE ON POWER SUPPLY FOR 10 OR 20 MINUTES. AT THE TIME OF THIS INCIDENT, ALL SEVEN BATTERY LEDS WERE ON AND THE IKUS WAS FUNCTIONING WELL WITH NO ISSUES. BERLIN HEART INC. SERVICE ENGINEER REVIEWED THE LOG FILES SENT BY THE SITE AND REPORTED THAT THE LOG FILES HAD INDICATED THAT THE IKUS WAS BEING USED ON BATTERY MODE MULTIPLE TIMES, FOR APPROXIMATELY 5-15 MINUTES AT A TIME WITHOUT ALLOWING FULLY RECHARGE THE BATTERIES. THIS WAS COMMUNICATED TO THE SITE. AT THIS TIME, THE SITE REPORTED THAT IT WAS USING A LONG POWER CORD AND AN EXTENSION CORD TO LIMIT BATTERY USAGE. ON (B)(6) 2016, THE SITE CALLED CA TO REPORT THAT THE IKUS HAD STOPPED PUMPING WHILE ON AN EXTENSION CORD AND THAT THE NURSE USED THE HAND-PUMP TO SUPPORT THE PATIENT UNTIL THE PATIENT COULD BE TRANSITIONED TO THE BACK-UP IKUS. THE NURSE REPORTED HEARING A CHIRPING ALARM FROM THE IKUS BEFORE CONFIRMING THE EXCOR BLOOD PUMP HAD STOPPED EJECTING PRIOR TO HAND PUMPING. THE PATIENT WAS PLACED ON THE BACK UP IKUS AND SUFFERED NO UNTOWARD EFFECT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5539026 ↗

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