FDAClass IIMay 8, 2024

Intellis AdaptiveStim Product Number 97715 recall

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

Why was Intellis AdaptiveStim Product Number 97715 recalled?

inability to reprogram one device

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00643169781719

Product
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Recalling firm
Medtronic Neuromodulation
Quantity
1 unit
Distribution
International distribution in the country of UK.
Recall date
May 8, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls