LifeSPARC 5900-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814112020623), received between Aug 17, 2022 and Oct 10, 2023 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (2 reports).

2 FDA recall records name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K183623, K211830); 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. Dec 5, 2022Class ITerminated

   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 · Recall details · FDA record ↗

2. Jul 21, 2022Class ITerminated

   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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183623, K211830. One submission often covers many models, so check the product and lot details in each record.

• Z-2465-2023 · Jun 30, 2023 · Open, Classified
  LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged com