Maestro 4000 Cardiac Ablation System (2020-01-13)
In plain language
This recall involves the Maestro 4000 Cardiac Ablation System sold in Canada. It's being recalled because it may continue to deliver radiofrequency energy after the foot switch is released. 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.
- Contact Boston Scientific Corporation for a firmware upgrade.
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Affected products
Maestro 4000 Cardiac Ablation System
Model: M00440000, M0044000D0, M0044000H0
Lot: 1002180997, 412170449, 1117170669, 419180824, 907180934
Why this matters
Unintended energy delivery
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: 1002180997, 412170449, 1117170669, 419180824, 907180934
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: M00440000, M0044000D0, M0044000H0
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?
Unintended energy delivery
What should consumers do?
Stop using the product immediately. Check model and serial numbers. Contact Boston Scientific Corporation for a firmware upgrade.
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. Unintended energy delivery
When was this product recalled?
This product was recalled on December 24, 2020.