ROTAFLOWRecalls & reported problems across all models
Maquet Cardiopulmonary AG · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ROTAFLOW model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 4
- Injuries reported
- 0
- Recalls
- 4
We found 4 models of ROTAFLOW by Maquet Cardiopulmonary AG in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2024 and Feb 27, 2026 — classified as 4 deaths, 10 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (6 reports).
4 FDA recall records name at least one of these models by its device identifier, 2 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
ROTAFLOW 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.
- Jan 8, 2024Open, Classified
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Z-0978-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 8, 2024Open, Classified
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Z-0977-2024 · Root cause: Process control · Recall details · FDA record ↗
- Aug 7, 2020Terminated
Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
Z-2957-2020 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported ROTAFLOW problems
Device problems
- Electrical /Electronic Property Problem6
- Pumping Stopped4
- Improper Flow or Infusion3
- Noise, Audible1
- Pumping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Cardiac Arrest2
- Insufficient Information2
ROTAFLOW models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROTAFLOW DrivePUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall4 deaths9 reports
- ROTAFLOW Console, English/ USPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall5 reports
- ROTAFLOW Centrifugal Pump, BIOLINEPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- ROTAFLOW Centrifugal Pump, SOFTLINEPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
Recent ROTAFLOW adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Pumping Stopped
THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED ON THE ROTAFLOW CONSOLE AND THE PUMP STOPPED DURING PATIENT TREATMENT. THE CUSTOMER REBOOTED THE DEVICE AND IT STARTED TO WORK. AFTERWARDS, THE ROTAFLOW WAS REPLACED ON THE PATIENT. THE CUSTOMER DID NOT REMEMBER WHICH EXACT ERROR MESSAGE OCCURRED ON THE ROTAFLOW CONSOLE. NO HARM TO ANY PERSON HAS BEEN REPORTED. A REPORT IS REQUIRED DUE TO THE UNEXPECTED PUMP STOP AND THE DEVICE EXCHANGE. COMPLAINT ID: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467516 ↗DeathJan 13, 2026Pumping Stopped
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 ↗MalfunctionDec 1, 2025Electrical /Electronic Property Problem; Pumping Stopped; Electrical /Electronic Property Problem; Pumping Stopped
COMPLAINT ID: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677919 ↗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 ↗MalfunctionSep 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE EVENT OCCURRED IN THE UNITED STATES OF AMERICA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. NO MORE INFORMATION PROVIDED. MORE INFORMATION REQUESTED BUT STILL PENDING. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO A PUMP STOP DURING USE, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975487 ↗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 ↗MalfunctionAug 5, 2025Improper Flow or Infusion; Improper Flow or Infusion
THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT THE ERROR MESSAGE ¿SIG ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. THERE WAS NO PUMP STOP. THE RPMS WERE VISIBLE BUT ON THE FLOW SCREEN JUST DASHES ¿---¿ WERE DISPLAYED. THE CONTACT CREAM WAS REAPPLIED AND THE HAND CRANK WAS USED. THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED EXCHANGE OF THE DEVICE DURING PATIENT TREATMENT A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22712194 ↗MalfunctionMay 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
MalfunctionApr 22, 2025Pumping Problem; Pumping Problem
COMPLAINT ID: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878911 ↗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 ↗
Other Maquet Cardiopulmonary AG products
All Maquet Cardiopulmonary AG devices →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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