Emblem S-ICD Pulse Generator recall in Canada: performance issue
In plain language
This recall involves Emblem S-ICD Pulse Generators and Emblem MRI S-ICD Pulse Generators sold in Canada. They are being recalled because a software issue could affect device performance. Contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
Emblem S-ICD Pulse Generator
Model: A209
Lot: 00802526548406, 00802526575167, 00802526599002, 00802526544101, 00802526575228, 00802526575105, 00802526575136, 00802526575143, 00802526575112, 00802526575211, 00802526575129, 00802526575181, 00802526575204
Emblem MRI S-ICD Pg
Model: A219
Lot: 00802526584404, 00802526590405, 00802526590436, 00802526581519, 00802526584411, 00802526590429
Why this matters
Performance issue
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: 00802526548406, 00802526575167, 00802526599002, 00802526544101, 00802526575228, 00802526575105, 00802526575136, 00802526575143, 00802526575112, 00802526575211, 00802526575129, 00802526575181, 00802526575204, 00802526584404, 00802526590405, 00802526590436, 00802526581519, 00802526584411, 00802526590429
- 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?
Performance issue
What should consumers do?
Contact the manufacturer if you require additional 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. Performance issue
When was this product recalled?
This product was recalled on October 17, 2023.
Is the BOSTON SCIENTIFIC CORPORATION brand affected by this recall?
Yes, BOSTON SCIENTIFIC CORPORATION products are affected by this recall. This recall involves Emblem S-ICD Pulse Generators and Emblem MRI S-ICD Pulse Generators sold in Canada. They are being recalled because a software issue could affect device performance. Contact the manufacturer for more information.