ROTAFLOW Console, English/ USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04037691562445), received between Apr 22, 2025 and Feb 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 22, 2025Pumping Problem; Pumping Problem

  COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878911 ↗

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-0678-2020 · Dec 3, 2019 · Terminated
  Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.