NA 560A (UDI 00763000244873)Recalls & reported problems
Medtronic, Inc. · MOTOR 560A EXTERNAL DRIVE SC SPCTRM PLX · 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 00763000244873), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Pumping 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.
Reports received per month
Most reported problems
Device problems
- Pumping 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.
MalfunctionNov 6, 2024Pumping Problem; Pumping Problem
MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS EXTERNAL DRIVE MOTOR INSTRUMENT DOES NOT REACH THE MAX RPM OF 4000. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20619615 ↗
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- Bio-Console® 560BCS1Medtronic, Inc. · Control, pump speed, cardiopulmonary bypass1 recall1 death121 reports
- LifeSPARC 5900-0001Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls1 death5 reports
- CP5 Pump Control PanelLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall53 reports
- LifeSPARC 5900-0000Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls0 reports
- CP5 Drive UnitLivaNova Deutschland GmbH · Control, pump speed, cardiopulmonary bypass1 recall32 reports
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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