SCPC w Temperature & PressureRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04033817901013), received between Aug 2, 2022 and Oct 17, 2025 — classified as 7 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325564 ↗
• MalfunctionMar 19, 2025Unexpected Shutdown; Unexpected Shutdown

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642187 ↗
• MalfunctionApr 23, 2024Unexpected Shutdown; Unexpected Shutdown

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A CENTRIFUGAL PUMP CONSOLE SWITCHED OFF DURING OPERATION EVEN THOUGH THE BATTERY CAPACITY IS 60-70% AMOUNTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161793 ↗
• MalfunctionApr 2, 2024Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING A PROCEDURE, THE SCPC INTERMITTENTLY DISPLAYED THE ALARM INCONSISTENT ACTUAL VALUE IMPULSES (E78). MEANWHILE, THE PUMP WAS HOT TO THE TOUCH AND THE FLOW OF BLOOD WAS UNSTABLE. THERE IS NO REPORT OF ANY PATIENT INJURY. THE RELEVANT PERSONAL COULD NOT TROUBLESHOOT THE PROBLEM AND THE TECHNICIAN COULD NOT JUDGE FOR THE CAUSE EITHER: THE SCPC IS CURRENTLY OUT OF SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019120 ↗
• MalfunctionNov 14, 2023Pumping Stopped; Pumping Stopped

  SEE INITIAL REPORT.

  Patient problems: Coma; Ischemia Stroke; Shock

  MAUDE report 18130127 ↗
• MalfunctionApr 13, 2023Pumping Problem; Pumping Problem

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE KNOB OF A CENTRIFUGAL PUMP CONSOLE DID NOT TURN PROPERLY. THE ISSUE OCCURRED DURING MAINTENANCE ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731503 ↗
• MalfunctionAug 2, 2022Break; Break

  LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF A SCPC CENTRIFUGAL PUMP SPEED CONTROL KNOB DEFECTIVE. THE ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146246 ↗