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Sarns™ Centrifugal System 6379Recalls & reported problems

Terumo Cardiovascular Systems Corporation · Centrifugal Pump Speed Control Module · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886799000076), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Display/Image” (1 report).

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.

Most reported problems

Device problems

  • No Display/Image1
  • Unable to Obtain Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 5, 2021No Display/Image; Unable to Obtain Readings; No Display/Image; Unable to Obtain Readings

    THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE UNIT DID NOT DISPLAY THE FLOW BOARD SOFTWARE VERSION, ONLY DASHES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11425364 ↗

Other Control, Pump Speed, Cardiopulmonary Bypass devices

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Sources and updates

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