EMBLEM S-ICD PULSE GENERATOR & EMBLEM MRI S-ICD PG (2020-12-03)
In plain language
This recall involves EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD PG medical devices sold in Canada. They are being recalled because a low voltage capacitor can cause the battery to deplete too quickly. Patients should consult their healthcare professional for guidance.
What to do
- Stop using the product immediately.
- Check model/serial numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
EMBLEM S-ICD PULSE GENERATOR
Model: A209
Lot: 60A209400, 60A209600
EMBLEM MRI S-ICD PG
Model: A219
Lot: 60A219899, 60A219803
Why this matters
Battery depletion
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: 60A209400, 60A209600, 60A219899, 60A219803
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: A209, A219
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?
Battery depletion
What should consumers do?
Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it as instructed.
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. Battery depletion
When was this product recalled?
This product was recalled on December 18, 2020.
Is the EMBLEM brand affected by this recall?
Yes, EMBLEM products are affected by this recall. This recall involves EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD PG medical devices sold in Canada. They are being recalled because a low voltage capacitor can cause the battery to deplete too quickly. Patients should consult their healthcare professional for guidance.