Reported Jan 20, 2021 · Ongoing

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product…

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

  • Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 -
  • Product Usageintended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy
Lot codes and dates
  • Software version 1.3.80
Amount recalled
7960 downloads

Where it was sold

  • Nationwide

Why it was recalled

A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

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