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High RiskFDAfda-Z-0860-2021SOFTWARE DEFECT

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended fo...

Units Affected
7,960
Recall Date
November 12, 2020
Issuing Agency
Hazard
Software Defect

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0860-2021.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0860-2021.

Recall ongoing. Follow firm instructions.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Medtronic Neuromodulation or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0860-2021.

Medtronic Neuromodulation

FDA

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Medtronic Neuromodulation Recall FAQ

Medtronic Neuromodulation is the subject of a medical implants safety report: Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended fo.... The notice was published on November 12, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 7,960 units are potentially affected.