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NA 560BC1Recalls & reported problems

Medtronic, Inc. · CONSOLE 560BC1 CONTROL WO/SAFETY BRD MEE · 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 00643169315839), received between Jun 23, 2023 and Jun 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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

  • Mechanical Problem1

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.

  • MalfunctionJun 23, 2023Mechanical Problem; Mechanical Problem

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE THIS BIO-CONSOLE INSTRUMENT HAD A MOTOR MALFUNCTION ERROR. USE OF THE INSTRUMENT WAS CONTINUED AND THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION: THE HANDCRANK WAS NOT USED AT ANY STAGE DURING THE PROCEDURE TO MAINTAIN FLOW. THE FLOW INTERFERENCE WENT AWAY WITHIN MOMENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17189933 ↗

Other Control, pump speed, cardiopulmonary bypass devices

All Control, pump speed, cardiopulmonary bypass devices →

Sources and updates

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