Bio-ConsoleRecalls & reported problems across all models
Medtronic, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Bio-Console model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 314
- Deaths reported
- 1
- Injuries reported
- 22
- Recalls
- 1
We found 7 models of Bio-Console by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 314 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2016 and Sep 11, 2026 — classified as 1 death, 22 injuries, 291 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (133 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Bio-Console recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 3, 2021Open, Classified
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.
Z-1313-2021 · Root cause: Component change control · names 4 of these models · Recall details · FDA record ↗
Most reported Bio-Console problems
Device problems
- Battery Problem133
- Device Alarm System86
- Power Problem86
- Display or Visual Feedback Problem24
- Smoking18
- Electrical /Electronic Property Problem17
- Obstruction of Flow11
- Mechanical Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions306
- No Consequences Or Impact To Patient4
- Hypoxia2
- Low Blood Pressure/ Hypotension2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cardiac Arrest1
- Cardiovascular Dysfunction/Insufficiency1
- Ischemia1
Bio-Console models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bio-Console® 560BCS1Control, pump speed, cardiopulmonary bypass1 recall129 reports
- Bio-Console® 560BCS1Control, pump speed, cardiopulmonary bypass1 recall1 death121 reports
- Bio-Console® 560BCS1Control, pump speed, cardiopulmonary bypass1 recall30 reports
- Bio-Console® 560BC1Control, pump speed, cardiopulmonary bypass1 recall21 reports
- Bio-Console® R560BCS1Control, pump speed, cardiopulmonary bypass9 reports
- Bio-Console® E560BCS1Control, pump speed, cardiopulmonary bypass3 reports
- Bio-Console® R560BCS1Control, pump speed, cardiopulmonary bypass1 report
Recent Bio-Console adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Battery Problem
Medtronic received information that prior to use of a Bio-Console 560 instrument, it was reported that the instrument did not operate on battery power. The instrument was replaced. There was no patient involvement, so no adverse effect occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728613 ↗MalfunctionSep 7, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50647475 ↗MalfunctionSep 2, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567283 ↗MalfunctionAug 26, 2026Device Alarm System; Battery Problem
Medtronic received information that at an unspecified time, this Bio-Console 560 instrument had an error code 69 (SC MPU UPS open battery detected hard error). The use of the instrument was unspecified. There was no adverse patient effect reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449255 ↗MalfunctionAug 14, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255330 ↗MalfunctionAug 4, 2026Device Alarm System; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130847 ↗MalfunctionMay 14, 2026Power Problem
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A MOTOR CONTROLLER MALFUNCTION. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25169006 ↗MalfunctionMay 4, 2026Power Problem
DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT WOULD NOT POWER ON. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073340 ↗MalfunctionApr 23, 2026Device Alarm System; Battery Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE (DURING SETUP) OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED THAT THE BASE UNIT DISPLAYED AN ERROR CODE 43 AFTER BOOTING UP - BATTERY CHARGE FAILURE. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24970990 ↗MalfunctionApr 16, 2026Device Alarm System
DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE 560 INSTRUMENT HAD AN ERROR 69 (SC MPU UPS OPEN BATTERY DETECTED HARD ERROR). THE INSTRUMENT HAS NOT BEEN IN USE FO THE PAST 12 MONTHS AND WAS NOT CONNECTED TO POWER SINCE. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903275 ↗MalfunctionApr 16, 2026Device Alarm System; Electrical /Electronic Property Problem; Obstruction of Flow
DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE INSTRUMENT HAD A DEFECTIVE M/P BOARD. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PRESSURE FAILURE CAUSED A HARD FAULT AND WOULD LIKELY HAVE STOPPED THE DEVICE. THERE WAS AN ERROR THAT CAME UP DURING THE PRESSURE TESTING STEP OF THE PM. THE BOARD COULD NOT BE CALIBRATED AND THE SYSTEM DELIVERED A HARD FAULT WHEN UNDER PRESSURE. THE FAULT WAS ERROR 66 OFFSET HARD ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903210 ↗MalfunctionApr 1, 2026Battery Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A BATTERY FAILURE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758703 ↗MalfunctionMar 31, 2026Device Alarm System; Power Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE BASE INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT DISPLAYED AN ERROR CODE 43 AFTER BOOTING UP. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24739387 ↗MalfunctionMar 24, 2026Power Problem
IT WAS REPORTED THAT DURING THE ANNUAL PREVENTIVE MAINTENANCE INSPECTION OF THE BIO-CONSOLE 560 CONTROLLER INSTRUMENT THE INSTRUMENT KEPT ALARMING "AC POWER FAILURE" WHEN PLUGGED INTO AC POWER. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672339 ↗MalfunctionFeb 16, 2026Battery Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO CONSOLES 560 INSTRUMENT, IT WAS REPORTED THAT THIS UNIT HAD A BATTERY ISSUE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345533 ↗
Other Medtronic, Inc. products
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- CAPSUREFIX NOVUS17 models · 27,547 reports
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- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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