Deep Brain Stimulation programmer recall in Canada: MRI risk
In plain language
This recall involves Deep Brain Stimulation Clinician and Patient Programmer Applications and related devices sold in Canada. It's being recalled because incorrect MRI eligibility information could lead to tissue damage. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer for more information.
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Affected products
Pocket Adaptor Kit For Deep Brain Stimulation
Model: 64001, 64002
Lot: More than 10 numbers, contact manufacturer.
Activa SC - Neurostimulator
Model: 37602, 37603
Lot: More than 10 numbers, contact manufacturer.
Activa Clinician Programmer Application For Deep Brain Stimulation
Model: A610
Lot: More than 10 numbers, contact manufacturer.
Patient Programming Application For Deep Brain Stimulation
Model: A620
Lot: More than 10 numbers, contact manufacturer.
Percept PC Brainsense Deep Brain Stimulation Implantable Neurostimulator
Model: B35200
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Tissue damage from incorrect MRI exposure
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 37602, 37603, 64001, 64002, A610, A620, B35200
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Tissue damage from incorrect MRI exposure
What should consumers do?
Stop using the product immediately. Contact the manufacturer for more information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Tissue damage from incorrect MRI exposure
When was this product recalled?
This product was recalled on June 5, 2024.
Is the MEDTRONIC INC brand affected by this recall?
Yes, MEDTRONIC INC products are affected by this recall. This recall involves Deep Brain Stimulation Clinician and Patient Programmer Applications and related devices sold in Canada. It's being recalled because incorrect MRI eligibility information could lead to tissue damage. Stop using the product and follow the return/repair steps in the official notice.