LifeSPARC 5800-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814112020609), received between Jan 31, 2022 and Jan 29, 2025 — classified as 1 death, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K153295, K183623); 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 18, 2026.

Recalls naming this device

1. Jun 30, 2023Class IIOpen, Classified

   Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

   Z-2465-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264272 ↗
• MalfunctionMay 24, 2024Backflow; Infusion or Flow Problem; Backflow; Infusion or Flow Problem

  LIVANOVA RECEIVED A REPORT THAT AFTER SETTING UP A LIFESPARC PUMP, BLOOD WAS MOVING BACKWARDS THROUGH THE PUMP AND OXYGENATOR. THE CIRCUIT WAS PRIMED AND HANDED OFF TO THE PHYSICIAN TO CONNECT TO THE CANNULAS, AND WHEN THEY WERE UNCLAMPED AND ECMO WAS INITIATED THE BLOOD WAS OBSERVED AND MEASURED TO BE FLOWING BACKWARDS. IT WAS CHECKED BY 2 PHYSICIANS AND 2 ECMO SPECIALISTS FOR PROPER PLACEMENT OF THE CANNULAS AND CORRECT FLOW PROBE POSITION. THE DISPLAY SCREEN REPORTEDLY SHOWED A NEGATIVE FLOW. THE CIRCUIT WAS CLAMPED AND REMOVED FROM PATIENT AND A NEW NON-LIVANOVA DEVICE WAS PRIMED AND PLACED ON THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392469 ↗
• MalfunctionDec 21, 2023Infusion or Flow Problem; Infusion or Flow Problem

  LIVANOVA RECEIVED A REPORT THAT, UPON INITIATING PATIENT SUPPORT, THE USER WAS UNABLE TO GET LIFESPARC PUMP FLOWS ABOVE 1.0LPM DESPITE A MAX SPEED OF 7500 RPM. THERE WERE NO CLAMPS PRESENT ON THE CIRCUIT OR CANNULAS AND THERE WAS NO AIR AT THE TIME OF PRIMING. THE CIRCUIT WAS SWAPPED OUT TO ANOTHER PUMP AND SPEED AND FLOWS WERE ADEQUATE FOLLOWING THE CHANGE (5500 RPM, 4LPM). WHILE THE PATIENT DID DIE FOLLOWING THE EVENT, THE HOSPITAL HAS STATED THE DEATH WAS RELATED TO PATIENT CONDITION. THE PATIENT WAS ALREADY RECEIVING CPR PRIOR TO GOING ON SUPPORT. THERE IS NO SPECIFIC ALLEGATION OF AN ADVERSE EVENT WHICH OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372729 ↗
• MalfunctionDec 21, 2023Backflow; Infusion or Flow Problem; Backflow; Infusion or Flow Problem

  LIVANOVA RECEIVED A REPORT THAT AFTER SETTING UP A LIFESPARC PUMP, BLOOD WAS MOVING BACKWARDS THROUGH THE PUMP. THE MEDICAL TEAM INDICATED THAT BLOOD WAS COMING IN THROUGH THE OUTLET AND RETURNING THROUGH THE INLET, SUGGESTING BLOOD WOULD HAVE BEEN FLOWING FROM THE ARTERIAL SYSTEM AND RETURNED TO THE VENOUS SYSTEM. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS EVENT, HOWEVER CARE WAS WITHDRAWN THE FOLLOWING DAY AND THE PATIENT DID DIE. THE CUSTOMER HAS NOT INDICATED ANY RELATIONSHIP BETWEEN THE MALFUNCTION AND THE PATIENT DEATH THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372323 ↗
• DeathAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA RECEIVED A REPORT THAT A LIFESPARC PUMP EXPERIENCED LOW FLOW DURING SUPPORT OF A PATIENT FOLLOWING A MOTOR VEHICLE ACCIDENT. THE PATIENT WAS REPORTED TO HAVE A PERICARDIAL CONTUSION WITH BILATERAL FEMURS BROKEN AND WAS INTUBATED BUT WAS NOT ACHIEVING OXYGEN SATURATION DESPITE MAX VENT SETTING. ABOUT 3 HOURS LATER, THE PATIENT STARTED TO EXPERIENCE LOW FLOW. THE NURSE REPORTED THAT THEY WERE GIVING A LARGE AMOUNT OF FLUID YET WERE UNABLE TO IMPROVE THE FLOW AND IT EVENTUALLY DROPPED TO LESS THAN 1.0 LPM. THE TEAM PERFORMED AN EMERGENT SURGERY TO OPEN THE ABDOMINAL CAVITY AND PRESSURES WERE REPORTEDLY GREATER THAN 500MMHG. PRIOR TO THIS PROCEDURE, THE LIFESPARC CIRCUIT WAS CLAMPED OFF DUE TO LOW FLOW. SOON AFTER THE PROCEDURE THE PATIENT LOST PRESSURE AND DIED. THE ECMO COORDINATORS REPORTED THAT THEY DID NOT FEEL AS IF THE LIFESPARC PUMP FAILED AND REPORTED THE EVENT FOR DUE DILIGENCE PURPOSES.

  Patient problems: Reduced Blood Flow

  MAUDE report 17596645 ↗
• MalfunctionAug 10, 2023Infusion or Flow Problem; Infusion or Flow Problem

  LIVANOVA RECEIVED A REPORT THAT A TANDEMLIFE OXYGENATOR FAILED AFTER A VERY SHORT PERIOD OF TIME WHILE ON ECPR (EXTRACORPOREAL CARDIOPULMONARY RESUSCITATION) SUPPORT. THE OXYGENATOR WAS CHANGED OUT TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500775 ↗
• MalfunctionJul 17, 2023Obstruction of Flow; Obstruction of Flow

  LIVANOVA RECEIVED A REPORT THAT A TANDEMLIFE OXYGENATOR ABRUPTLY EXPERIENCED ZERO FLOW DURING SUPPORT. USING SUPER THERAPEUTIC ANTICOAGULATION, THE USER WAS INITIALLY ABLE TO ACHIEVE THE 4.0LPM GOAL FOR PATIENT BLOOD FLOW, HOWEVER THIS DECREASED TO 2.5LPM WITHIN 5 MINUTES OF SUPPORT WITHOUT CHANGING THE PUMP SPEED. THE USER ATTEMPTED TO TROUBLESHOOT BY RE-POSITIONING THE VENOUS DRAINAGE CANNULA, WHICH REQUIRED A MOMENTARY PAUSE OF SUPPORT. UPON RE-INITIATING SUPPORT, ZERO FLOW WAS ABLE TO BE ACHIEVED VIA THE CIRCUIT. A NEW CIRCUIT WAS PRIMED AND FLOW WAS INITIATED AT APPROPRIATE FLOW. THE REPLACED CIRCUIT WAS INSPECTED FOR CLOTTING BUT NO THROMBUS WAS IDENTIFIED, THOUGH THE OXYGENATOR WAS UNABLE TO DRAIN EITHER BY GRAVITY OR SYRINGE SUCTION. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337986 ↗
• InjuryMay 4, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED A REPORT THAT THE LIFESPARC PUMP STOPPED AND SHOWED ZERO FLOW DURING VA ECMO SUPPORT. THE STAFF STATED THAT THE LIFESPARC CONTROLLER WAS STILL FUNCTIONING PROPERLY AND THEY DID NOT TOUCH THE PUMP TO FEEL IF IT WAS STILL WORKING. FIBRIN STRANDS WERE NOTICE AT THE TOP OF THE PUMP NOSE CONE PRIOR TO THE EVENT. THE PATIENT REPORTEDLY CODED AND THE STAFF INITIATED A CIRCUIT CHANGE OUT IMMEDIATELY. THE PATIENT WAS REVIVED USING CHEST COMPRESSIONS AND WAS STABILIZED.

  Patient problems: Cardiac Arrest

  MAUDE report 16870019 ↗
• MalfunctionJan 31, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT DURING PATIENT SUPPORT WITH A LIFESPARC PUMP, LOW FLOW WAS NOTED AND THE SYSTEM CORRECTLY ALARMED FOR LOW FLOW. REPORTEDLY, FLOW DECREASED FROM 3.5 LPM TO 0.5 LPM. THE PUMP WAS CHANGED OUT AND THE ISSUE COULD BE SOLVED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13393111 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153295, K183623. One submission often covers many models, so check the product and lot details in each record.

• Z-0926-2023 · Dec 5, 2022 · Terminated
  SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an ex
• Z-1763-2022 · Jul 21, 2022 · Terminated
  TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.