LifeSPARCRecalls & reported problems across all models

We found 5 models of LifeSPARC by Cardiacassist, Inc. in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2022 and Jan 29, 2025 — classified as 2 deaths, 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (6 reports).

4 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

LifeSPARC recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 30, 2023Open, 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 ↗

2. Dec 5, 2022Terminated

   A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.

   Z-0926-2023 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

3. Jul 21, 2022Terminated

   Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

   Z-1763-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

4. Oct 14, 2021Open, Classified

   Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)

   Z-0311-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported LifeSPARC problems

LifeSPARC models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LifeSPARC 5900-0001

  Control, Pump Speed, Cardiopulmonary Bypass
  2 recalls1 death5 reports
• LifeSPARC 5900-0000

  Control, Pump Speed, Cardiopulmonary Bypass
  2 recalls0 reports
• LifeSPARC 5800-1000

  Accessory Equipment, Cardiopulmonary Bypass
  1 recall1 death9 reports
• LifeSPARC 5820-3118

  Dilator, Vessel, For Percutaneous Catheterization
  1 recall0 reports
• LifeSPARC 5800-0000

  Accessory Equipment, Cardiopulmonary Bypass
  2 reports

Recent LifeSPARC adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionNov 3, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED A REPORT THAT A LIFESPARC PUMP STOPPED AND WAS UNABLE TO BE RESTARTED DURING SUPPORT. THE USER ATTEMPTED TO PRIME THE PUMP WITHOUT A LIVANOVA REPRESENTATIVE PRESENT AND DESCRIBED PUTTING AN UNSPECIFIED AMOUNT OF SALINE INTO THE CIRCUIT AND PLACING BOTH ENDS OF THE CIRCUIT INTO A BASIN TO ATTEMPT A BASIN PRIME. THE PUMP WAS STARTED AND INITIALLY RAN, BUT USER REPORTED THAT IT STOPPED SHORTLY AFTER AND COULD NOT BE RESTARTED. THE USER REPORTEDLY ATTEMPTED A RESTART OF THE LIFESPARC CONTROLLER, PLUGGING IN THE DRIVE LINE SEVERAL TIMES WITH NO IMPROVEMENT. THE USER INDICATED THAT THEY POTENTIALLY HAD AN "AIR LOCK" IN THE PUMP HEAD OR THAT THE DRIVE LINE PLUG POTENTIALLY GOT WET BUT WERE UNABLE TO SPECIFY FURTHER. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069058 ↗
• MalfunctionOct 10, 2023Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  DURING RECEIVING OF A LIFESPARC CONTROLLER RETURNED TO LIVANOVA FOR PREVENTATIVE MAINTENANCE, CASE CRACKING AND DAMAGE WAS FOUND ON THE TOP LEFT OF THE ENCLOSURE AND THE BOTTOM OF THE FRONT ENCLOSURE WHERE THE PUMP AND FLOW CONNECTORS RESIDE. THE UNIT WAS PACKAGED CORRECTLY IN AND THERE WAS NO DAMAGE TO THE PACKAGING, SUGGESTING THE DAMAGE OCCURRED AT THE CUSTOMER SITE. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS REVEALED THAT THE CONTROLLER WAS DAMAGED PRIOR TO RETURN. IT IS UNKNOWN HOW THE DAMAGE OCCURRED OR IF THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908659 ↗
• 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 ↗
• DeathAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA RECEIVED A REPORT THAT A LIFESPARC CONTROLLER / DOCK 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 CONTROLLER / DOCK FAILED AND REPORTED THE EVENT FOR DUE DILIGENCE PURPOSES.

  Patient problems: Reduced Blood Flow

  MAUDE report 17591877 ↗
• 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 ↗
• MalfunctionJul 3, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED A REPORT THAT A LIFESPARC PUMP BEGAN MAKING NOISES AND STOPPED DURING SUPPORT. THE NOISY PUMP WAS NOTICED BY A FAMILY MEMBER OF THE PATIENT AND WHEN INSPECTED BY A NURSE, IT WAS OBSERVED THAT THE PUMP HAD COMPLETELY STOPPED AND THE CONTROLLER BEGAN ALARMING. THE PATIENT WAS ON SUPPORT FOR 10 DAYS AT THE TIME OF THE PUMP STOP. THE ENTIRE CIRCUIT WAS SWAPPED OUT AND REPLACED AND THE ISSUE WAS RESOLVED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252959 ↗
• MalfunctionMay 22, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED REPORT THAT A LIFESPARC CONTROLLER EXPERIENCED A PUMP STOP DURING PATIENT SUPPORT AND THE SCREEN DISPLAYED A RED BANNER FOR STOPPAGE AND NO LED LIGHTS WERE LIT. PRIOR TO THE EVENT THE PATIENT WAS AMBULATED, THE STAFF WAS DOING ROUTINE CHECKS AND MOVED THE FLOW SENSOR. THE PATIENT LOST HEMODYNAMIC SUPPORT AND THE USER ATTEMPTED TO RESTART THE PUMP WHICH WAS UNSUCCESSFUL ON THE FIRST ATTEMPT. THEY TRIED A SECOND TIME AND THE PUMP RESTARTED SUCCESSFULLY. PATIENT SUPPORT CONTINUED AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979910 ↗
• 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 17, 2023Pumping Stopped; Pumping Stopped

  LIVANOVA RECEIVED A REPORT THAT THE LIFESPARC PUMP STOPPED RUNNING DUE TO AN ERROR/ALARM DURING SUPPORT WITH A LIFESPARC CONTROLLER. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185434 ↗
• MalfunctionAug 17, 2022Battery Problem; Noise, Audible; Intermittent Loss of Power; Battery Problem; Noise, Audible; Intermittent Loss of Power

  LIVANOVA RECEIVED A REPORT THAT A LIFESPARC CONTROLLER USED FOR DEMO PURPOSES EXPERIENCED UNEXPECTED POWER LOSS AT RANDOM INTERVALS AND PRODUCED A RATTLING NOISE. IN ADDITION, THE BATTERIES WERE STUCK IN THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245505 ↗