VitalFlow Console 58100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10850007732247), received between Oct 22, 2025 and Mar 20, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (9 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 3, 2025Open, Classified

   As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

   Z-0509-2026 · Root cause: Software in the Use Environment · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Pumping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, DURING INITIAL PRODUCT TRAINING WITH CLINICAL TEAM, OF A VITAL FLOW CONSOLE INSTRUMENT, IT WAS REPORTED THAT THE CONSOLE WOULD NOT PROVIDE RPM FOR ROUGHLY 60-90 SECONDS AFTER START-UP, AND ON SHUT DOWN THE SCREEN FROZE, NECESSITATING A HARD RESET. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647332 ↗
• MalfunctionFeb 20, 2026Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT DURING USE OF THE VITALFLOW CONSOLE INSTRUMENT, THERE WAS A SIGNIFICANT INCREASE IN PRESSURE DIFFERENTIAL (DELTA P) FROM 50 TO 70, WITH A SUSPECTED CLOT IN THE PUMP HEAD THAT WAS BELIEVED TO HAVE MOVED FORWARD TO THE PREOXY. AN E10 ALARM, WHICH IS A PROTECTIVE ALARM THAT STOPS THE FLOW, WAS TRIGGERED, RESULTING IN FLOWS STOPPING FOR APPROXIMATELY 15-20 SECONDS. A LOUD NOISE WAS HEARD COMING FROM THE MOTOR, WHICH RESOLVED AFTER THE RETURN OF FLOW. THE PATIENT REMAINED ON THE SAME AMOUNT OF SUPPORT AFTER THE EVENT AND HAD BEEN ON SUPPORT FOR 41 DAYS AT THE TIME. THE PATIENT SUBSEQUENTLY DIED, WITH THE DEATH NOTED AS PRESUMABLY UNRELATED TO THE EVENT. AN ATTEMPT TO RETRIEVE DATA FROM THE CONSOLE WAS IN PROGRESS AT THE TIME OF THE REPORT. IT WAS DETERMINED THAT THE CONSOLE AND MOTOR DRIVE SHOULD BE CHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT WHEN THE CASE LOGS WERE REVIEWED, THE CUSTOMER NOTICED THAT THERE WAS AN E60 ONSET ALARM THAT APPEARED ABOUT A MINUTE BEFORE THE E10 ONSET AND THEN IT CLEARED AFTER THE E10 CLEARED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399063 ↗
• MalfunctionNov 11, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING EDUCATIONAL USE WITH A NON-STERILE PRIMED CIRCUIT, THE VITALFLOW CONSOLE CONTINUED TO DISPLAY AN E10 ERROR (PUMP SPEED IS 5% UNDER SET SPEED) AFTER THE COMPLETION OF AN E70 RELATED SOFTWARE UPDATE. THE CUSTOMER UNPLUGGED AND PLUGGED THE DRIVE MOTOR CABLE IN COMPLETELY, CHECKED ALL OTHER CONNECTIONS, CHANGED THE DISPOSABLE PUMP HEAD, AND PERFORMED A HARD RESET, BUT THE ERROR PERSISTED. THE USE OF THE DEVICES WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520237 ↗
• MalfunctionOct 30, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A VITALFLOW CONSOLE, IT WAS REPORTED THAT THE SCREEN WENT WHITE BRIEFLY AND THEN DISPLAYED ERROR CODE 70. 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 23422524 ↗
• MalfunctionOct 29, 2025Device Alarm System; Display or Visual Feedback Problem; Component Missing; Device Alarm System; Display or Visual Feedback Problem; Component Missing

  IT WAS REPORTED THAT AFTER USE, A VITALFLOW CONSOLE WAS ASSOCIATED WITH AN ALLEGED PRODUCT ISSUE IN WHICH THERE WAS AN ERROR E70 AND THE SCREEN WENT WHITE. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412255 ↗
• MalfunctionOct 28, 2025Device Alarm System; Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Device Alarm System; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE USE OF THE VITALFLOW CONSOLE INSTRUMENT, THE INSTRUMENT TOUCH SCREEN WAS RESPONDING SLOWLY TO TOUCH INTERACTIONS AND SUBSEQUENTLY WENT BLANK FOR 1 TO 2 MINUTES. THE SCREEN THEN RETURNED TO NORMAL OPERATION. THE CONSOLE WAS USED TO COMPLETE THE PROCEDURE AND SWITCHED OUT FOLLOWING THE EVENT. THIS IS RELATED TO AN E70 ERROR CODE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO OTHER EQUIPMENT IN THE ROOM, PARTICULARLY HIGH FREQUENCY DEVICES. THE INSTRUMENT WAS NOT IN A ROOM ADJACENT TO OTHER EQUIPMENT WHICH WAS CAPABLE OF GENERATING RADIO FREQUENCY ENERGY OR HIGH-POWER DEVICES WHEN THE ERROR OCCURRED. IT WAS STATED THAT THE INSTRUMENT WAS NOT BEING MOVED OFTEN. IT WAS MOVED JUST TO TRANSPORT ON OCCASION TO THE OPERATING ROOM (OR) OR COMPUTED TOMOGRAPHY (CT). IT WAS STATED THAT PATIENTS WHO WERE WALKING THE INSTRUMENT WOULD BE MOVED MORE BUT THIS IS NOT EVERY PATIENT. THE INSTRUMENT WAS NOT MOVED RIGHT BEFORE THIS ISSUE HAPPENED. IT WAS STATED THAT THE AIR/OXYGEN BLENDER WAS MOUNTED ON THE CART AND THE HEATER/COOLER WAS ON THE BOTTOM SHELF. THE INSTRUMENT WAS CLEANED BY WIPING IT WITH S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401057 ↗
• MalfunctionOct 24, 2025Device Alarm System; Display or Visual Feedback Problem; Device Alarm System; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS AN ALLEGED PRODUCT ISSUE WITH THE VITALFLOW CONSOLE INSTRUMENT. DURING USE, THE VITALFLOW SCREEN TURNED WHITE WHILE THE PUMP CONTINUED SPINNING. THE CUSTOMER INFORMED DURING A PHONE CALL THAT THE MC3 LOGO FLASHED, AND THEN THE SCREEN RETURNED TO NORMAL. THE ALARM HISTORY WAS CHECKED, CONFIRMING AN E70 ERROR. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO IMPACT TO THE PATIENT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377213 ↗
• MalfunctionOct 23, 2025Device Alarm System; Display or Visual Feedback Problem; Device Alarm System; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING THE USE OF THE VITAFLOW CONSOLE INSTRUMENT, THE CONSOLE SCREEN WENT WHITE FOR ABOUT 30 SECONDS BEFORE RETURNING TO NORMAL. THE ALARM HISTORY INDICATED AN E70 ALARM. THE INSTRUMENT WAS REPLACED. THERE WAS NO IMPACT ON THE PATIENT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO EXTERNAL TRANSDUCERS WERE USED TO MEASURE ON THE INLET AND OUTLET SIDES. THE INSTRUMENT IS NOT CURRENTLY IN USE AND THE ISSUE ONLY OCCURRED ONCE. THE INSTRUMENT WAS NOT PLUGGED INTO A POWER STRIP WITH THE CORRECT AMPERAGE TO POWER ALL THE DEVICES THEY HAD PLUGGED INTO IT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO OTHER EQUIPMENT IN THE ROOM, PARTICULARLY HIGH FREQUENCY DEVICES. THE CONSOLE WAS NOT IN A ROOM ADJACENT TO OTHER EQUIPMENT WHICH IS CAPABLE OF GENERATING RADIO FREQUENCY ENERGY OR HIGH-POWER DEVICES WHEN THE ERROR OCCURRED. IT WAS STATED THAT THE CONSOLE WAS NOT BEING MOVED OFTEN, IT WAS JUST TO TRANSPORTED ON OCCASION TO THE OPERATING ROOM CT. PATIENT'S WHO ARE WALKING THE INSTRUMENT WILL BE MOVED MORE BUT THIS IS NOT EVERY PATIENT. THE CONSOLE WAS NOT MOVED RIGHT BEFORE THIS ISSUE HAPPENED. THE AIR/OXY BLENDER WAS MOUNTED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367682 ↗
• MalfunctionOct 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE VITALFLOW CONSOLE INSTRUMENT'S SCREEN WENT WHITE FOR 2 MINUTES WHILE AN ECMO NURSE WAS CHECKING THE ALARM HISTORY. THE PUMP CONTINUED TO RUN, AND THE RPMS WERE MAINTAINED ON THE SECONDARY INDICATOR LIGHT DURING THIS TIME. THE SCREEN RETURNED TO NORMAL AFTER 2 MINUTES, AND THE REST OF THE RUN WAS UNEVENTFUL. THE INSTRUMENT IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356239 ↗
• MalfunctionOct 22, 2025Device Alarm System; Display or Visual Feedback Problem; Device Alarm System; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A VITAL FLOW MOTOR DRIVE INSTRUMENT, IT WAS REPORTED THAT THE SCREEN WENT BLANK FOR 30 TO 60 SECONDS, BUT THE PUMP DID NOT SHUT OFF. WHEN THE SCREEN WENT BACK TO NORMAL, AN ERROR E70 WAS PRESENT IN THE ALARM HISTORY TAB. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE E70 CODE WAS THE FIRST AND ONLY ALARM CODE LISTED IN THE ALARM SCREEN AFTER THE GRAY SCREEN EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT IS STILL IN USE SO NOT RETURNED FOR SERVIEC.NO FURTHER ACTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356117 ↗
• MalfunctionOct 22, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS VITALFLOW CONSOLE INSTRUMENT HAD A BLANK/GREY SCREEN FOLLOWED BY ERROR E70. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SCREEN WAS NOT BEING TOUCHED BEFORE IT WENT BLANK. IT IS UNKNOWN WHETHER THE ALARM HISTORY TAB EVER ACCESSED BEFORE THE SCREEN WENT BLANK. WHEN THE SCREEN CAME BACK, ONLY ERROR CODE E70 WAS LISTED. THE INSTRUMENT WON'T BE SENT FOR REPAIR AT THIS TIME, SINCE IT IS AWAITING FOR A SOFTWARE UPDATE. NO FURTHER ACTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355963 ↗