ROTAFLOW DriveRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04037691258997), received between Nov 22, 2024 and Jan 13, 2026 — classified as 4 deaths, 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K991864); they may or may not involve this specific model.

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. Dec 3, 2019Terminated

   A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

   Z-0678-2020 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathJan 13, 2026Pumping Stopped

  COMPLAINT ID: (B)(4).

  Patient problems: Cardiac Arrest

  MAUDE report 24053485 ↗
• DeathJan 12, 2026Pumping Stopped

  THE EVENT OCCURRED IN EGYPT DURING TREATMENT. IT WAS REPORTED THAT THE PLS DRIVE FAILED AND THE PUMP STOPPED. THEREFORE, THE PLS SET AND HARDWARE WERE REPLACED TO A HLS SET AND CARDIOHELP DEVICE. FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT WAS CONNECTED TO V-A ECMO DUE TO A CARDIOGENIC SHOCK AND ARRESTED AFTER CANNULATION AND THEN HAD A RETURN OF SPONTANEOUS CIRCULATION (ROSC). LATER THE PATIENT ARRESTED A SECOND TIME WITH NO ROSC AFTER 36 HOURS. FOLLOWING PATIENT INFORMATION WAS SHARED: 16 YEARS OLD MALE WITH 70KG AND 170CM. NEW INFORMATION WAS RECEIVED ON 2026-01-07 THAT THE FAILURE WAS THAT THE CUSTOMER WAS NOT ABLE TO RAISE THE FLOW. THEREFORE, THE PLS SET AND ROTAFLOW WERE IMMEDIATELY REPLACED TO A HLS CIRCUIT WITH CARDIOHELP DEVICE. NO ALARM MESSAGE WAS DISPLAYED ON THE ROTAFLOW DEVICE. THE PATIENT ARRESTED IMMEDIATELY AFTER CONNECTION TO THE VA ECMO. THE FIRST CARDIAC ARREST WAS ON (B)(6) 2025 ON THE PLS SET/ROTAFLOW. THE SECOND CARDIAC ARREST WAS ON (B)(6) 2025 ON THE HLS SET/CARDIOHELP. THE CUSTOMER PERFORMED ADVANCED CPR, BUT THE PATIENT PASSED AWAY. THE PATIENT WAS CONNECTED TO THE ECMO DEVICE DUE TO SEVER CARDIOGENIC SHOCK. THE PATIENT HAD NO PRE MEDICAL HISTORY;

  Patient problems: Cardiac Arrest

  MAUDE report 24035412 ↗
• MalfunctionDec 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE EVENT OCCURRED IN SAUDI ARABIA. IT WAS REPORTED THAT ROTAFLOW DRIVE WAS FOUND TO BE DEFECTIVE. IF THE DEVICE REACHED 1000 RPM (REVOLUTIONS PER MINUTE) THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED. NO MORE INFORMATION PROVIDED. MORE INFORMATION REQUESTED BUT STILL PENDING. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862084 ↗
• MalfunctionNov 14, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552119 ↗
• DeathAug 13, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT DURING PREPARATION FOR A PLANNED CT SCAN ¿ PLANNED IN-HOUSE PATIENT TRANSPORT WITH VA ECMO FROM THE INTENSIVE CARE UNIT TO THE CT ¿ THE ROTAFLOW DRIVE UNIT WAS POSITIONED IN THE PATIENT BED AS PER INSTRUCTIONS. THE DRIVE PUMP WAS RUNNING CORRECTLY AT A FLOW RATE OF 2.6 L/MIN. SUDDENLY, THE ROTAFLOW FLOW INDICATOR ALERTED, AND THE FLOW INDICATOR WAS NO LONGER READABLE. AT THE SAME TIME, A SIGNIFICANTLY LOUDER ROTATION NOISE FROM THE DRIVE PUMP WAS AUDIBLE. AN IMMEDIATE, COMPLETE INSPECTION REVEALED THAT AIR HAD ENTERED THE SYSTEM. THE ARTERIAL LINE WAS IMMEDIATELY CLAMPED, AND THE ECMO SPEED WAS COMPLETELY REDUCED. AFTER IMMEDIATELY CLAMPING THE ARTERIAL LINE AND REDUCING THE ECMO SPEED, THE PERFUSIONISTS WERE IMMEDIATELY INFORMED, WITH THE URGENT INSTRUCTION TO IMMEDIATELY TRANSFER A FILLED, READY-TO-USE SYSTEM TO THE INTENSIVE CARE UNIT. THE SUBSEQUENT INSPECTION OF THE ECMO SYSTEM TOGETHER WITH THE ATTENDING PHYSICIANS REVEALED NO VISIBLE DAMAGE TO THE ECMO. ANALYSIS: DURING THE UKR'S ANALYSIS OF THE AFFECTED PRODUCTS, NO UNDESIRABLE SIDE EFFECTS, NO MALFUNCTION, NO APPLICATION ERROR, AND NO INADEQUACY OF THE INFORMATION PROVIDE

  Patient problems: Insufficient Information

  MAUDE report 22794352 ↗
• DeathAug 13, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT DURING PREPARATION FOR A PLANNED CT SCAN ¿ PLANNED IN-HOUSE PATIENT TRANSPORT WITH VA ECMO FROM THE INTENSIVE CARE UNIT TO THE CT ¿ THE ROTAFLOW DRIVE UNIT WAS POSITIONED IN THE PATIENT BED AS PER INSTRUCTIONS. THE DRIVE PUMP WAS RUNNING CORRECTLY AT A FLOW RATE OF 2.6 L/MIN. SUDDENLY, THE ROTAFLOW FLOW INDICATOR ALERTED, AND THE FLOW INDICATOR WAS NO LONGER READABLE. AT THE SAME TIME, A SIGNIFICANTLY LOUDER ROTATION NOISE FROM THE DRIVE PUMP WAS AUDIBLE. AN IMMEDIATE, COMPLETE INSPECTION REVEALED THAT AIR HAD ENTERED THE SYSTEM. THE ARTERIAL LINE WAS IMMEDIATELY CLAMPED, AND THE ECMO SPEED WAS COMPLETELY REDUCED. AFTER IMMEDIATELY CLAMPING THE ARTERIAL LINE AND REDUCING THE ECMO SPEED, THE PERFUSIONISTS WERE IMMEDIATELY INFORMED, WITH THE URGENT INSTRUCTION TO IMMEDIATELY TRANSFER A FILLED, READY-TO-USE SYSTEM TO THE INTENSIVE CARE UNIT. THE SUBSEQUENT INSPECTION OF THE ECMO SYSTEM TOGETHER WITH THE ATTENDING PHYSICIANS REVEALED NO VISIBLE DAMAGE TO THE ECMO. ANALYSIS: DURING THE UKR'S ANALYSIS OF THE AFFECTED PRODUCTS, NO UNDESIRABLE SIDE EFFECTS, NO MALFUNCTION, NO APPLICATION ERROR, AND NO INADEQUACY OF THE INFORMATION PROVIDE

  Patient problems: Insufficient Information

  MAUDE report 22791627 ↗
• MalfunctionMay 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975598 ↗
• MalfunctionFeb 19, 2025Noise, Audible; Noise, Audible

  THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ROTAFLOW DRIVE MAKES NOISE WHEN THE SPEED INCREASES. THE INCIDENT OCCURRED DURING USE. THE DEVICE WAS EXCHANGED WITHOUT CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGE OF THE DEVICE DURING USE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408411 ↗
• MalfunctionNov 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW AFTER THE UNIT WAS TURNED ON. THE DEVICE WAS NOT USED ON PATIENTS. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756625 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991864. One submission often covers many models, so check the product and lot details in each record.

• Z-2957-2020 · Aug 7, 2020 · Terminated
  Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving roller