LifeSPARC 5800-0000Recalls & reported problems
Cardiacassist, Inc. · LifeSPARC blood pump kit with accessories · Class 1
All models of LifeSPARC (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814112020593), received between Jul 3, 2023 and Nov 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Pumping Stopped2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Other Accessory Equipment, Cardiopulmonary Bypass devices
- LifeSPARC 5800-1000Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass1 recall1 death9 reports
- TandemLife LifeSPARC 5840-2415Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass1 recall0 reports
- NA Conv.kitMaquet Cardiopulmonary AG · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 recall0 reports
- NA INFUSION POLEMaquet Cardiopulmonary AG · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 recall0 reports
- CentriMag™ 201-50112Thoratec Corporation · ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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