Recall of Device Recall RestoreUltra and RestoreSensor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Reason
    Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. the use of this feature is determined by the physician and set using the clinician programmer. current labeling indicates the use of cycling improves device longevity and recharge interval.
  • Action
    Medtronic sent a Medical Device Correction letter dated February 2014 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: If you have patients with cycling enabled or wish to use cycling, use the updated calculations and graphs available online at to assess the impact of cycling on device longevity. Medtronic will update the product labeling in the second half of 2014. " Remind your patients to continue to check their battery status. Instructions on how to check battery status can be found in the patient programmer or recharger system manual. " Pain Stimulation Trialing Only: The cycling feature should not be enabled on the External Neurostimulator (ENS) when estimating device longevity because the resulting longevity estimate for non-rechargeable devices may not provide accurate information. Consignees were also instructed to acknowledge receipt of the notice by completing the attached reply form and returning it to Medtronic using the contact details on the reply form. For questions consignees can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7am - 6pm CST. For questions regarding this recall call 800-707-0933.


  • Model / Serial
    The first released affected product was released to the market in April, 2005.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution - all states including DC and Puerto Rico.
  • Product Description
    Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.
  • Manufacturer


  • Manufacturer Address
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source