FDA Warns – Citing serious injuries, MaxMobility/Permobil recalls SmartDrive Speed Control Dials used with their SmartDrive MX2+ Power Assist Devices

Late last month, Max Mobility/Permobil announced a nationwide recall of the SmartDrive Speed Control Dial used with their SmartDrive MX2+ Power Assist Device. As explained by the FDA, the recall applies only to the Speed Control Dial and not to the company’s automated wheelchair devices.

Max Mobility/Permobil notified customers of the recall involving model numbers MX2-3DCK and MX2-3DC of the SmartDrive Speed Control Dial on December 20, 2024. The SmartDrive Speed Control Dial represents one option users have for activating and deactivating the motor on the SmartDrive MX2+ Power Assist Device, which is an automated wheelchair. Other options for powering the wheelchair, as explained on the company’s website, include the SmartDrive MX2+ App, SwitchControl, and SwitchControl with mono jack. The SmartDrive Speed Control Dials included in the recall were sold between August 17, 2023, and November 21, 2024.

As of mid-December, the company received 646 complaints and three reports of serious injury linked to use of the impacted SmartDrive Speed Control Dials. Max Mobility/Permobil attributes the problem to a “material change” in the circuit board for the control dial. Users have experienced multiple issues caused by the device, such as:

  • an inability to stop the motor on the SmartDrive MX2+ Power Assist Device
  • unpredictable activation of the motor on the wheelchair even when the SmartDrive Speed Control Dial is set at zero
  • sudden and unpredictable loss of power to the SmartDrive Speed Control Dial
  • an inability to activate the motor in order to move the wheelchair

Serious injuries resulting from the faulty control dials have included “fractured hip, fractured tibia, and fractured malleolus bone.”

In their notification to customers, Max Mobility/Permobil shared instructions for requesting a replacement of the Speed Control Dial unit. Until the replacement has been received, customers should use an alternate option for powering their wheelchair, as referenced above. Continued use of the recalled SmartDrive Speed Control Dial increases the user’s risk of injury. For more information about the recall and replacement process, customers can visit this page of the company’s website.

Anyone with questions or concerns about the recall can contact the MaxMobility/Permobil technical support team Monday through Friday from 8:00 a.m. to 5:00 p.m. CST at (800) 736-0925.

 

If you or a loved one has suffered an injury or adverse health outcome linked to safety issues with a medical device, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to hospitals and health care providers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.