EMBLEM S-ICD Pulse Generator recall in Canada: electrical overstress risk
In plain language
This recall involves EMBLEM S-ICD Pulse Generators and EMBLEM MRI S-ICD PGs sold in Canada. They are being recalled because of a potential for electrical overstress during high voltage therapy. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and serial numbers.
- Follow instructions from your healthcare provider regarding this recall.
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Affected products
EMBLEM S-ICD PULSE GENERATOR
Model: A209
Lot: 60A209400, 60A209600
EMBLEM MRI S-ICD PG
Model: A219
Lot: 60A219800, 60A219803
Why this matters
Electrical overstress risk
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, 60A219800, 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?
Electrical overstress risk
What should consumers do?
Stop using the product immediately. Check model and serial numbers. Follow instructions from your healthcare provider regarding this recall.
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. Electrical overstress risk
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 Generators and EMBLEM MRI S-ICD PGs sold in Canada. They are being recalled because of a potential for electrical overstress during high voltage therapy. Stop using the product and follow the return/repair steps in the official notice.