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High RiskFDAfda-Z-1535-2021OTHER

Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with...

Units Affected
79,616
Recall Date
March 25, 2021
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1535-2021.

There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1535-2021.

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-1535-2021.

Medtronic Neuromodulation

FDA

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Medtronic Neuromodulation Recall FAQ

Medtronic Neuromodulation is the subject of a medical implants safety report: Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with.... The notice was published on March 25, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 79,616 units are potentially affected.