Automated Impella Controller recall in Canada: delayed alarm
In plain language
This recall involves the Abiomed Automated Impella Controller with software V8.2.3 sold in Canada. It's being recalled because of a delayed "purge system blocked" alarm when used with a specific Impella 5.5 set. Healthcare professionals should not use the affected controller unless the software is updated to v10.1 or above.
What to do
- Stop using the product immediately if the software is V8.2.3 and not updated.
- Contact the manufacturer for additional information.
- Ensure software is updated to v10.1 or above before use.
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Affected products
Automated Impella Controller Software version 8.2.3
Model: 0042-0000-CA, 0042-0040-CA
Why this matters
Medical device 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 model number
Model numbers are typically on the product label or packaging.
Affected models: 0042-0000-CA, 0042-0040-CA
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?
Medical device performance issue
What should consumers do?
Stop using the product immediately if the software is V8.2.3 and not updated. Contact the manufacturer for additional information. Ensure software is updated to v10.1 or above before use.
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. Medical device performance issue
When was this product recalled?
This product was recalled on February 25, 2026.
Is the Abiomed Inc. brand affected by this recall?
Yes, Abiomed Inc. products are affected by this recall. This recall involves the Abiomed Automated Impella Controller with software V8.2.3 sold in Canada. It's being recalled because of a delayed "purge system blocked" alarm when used with a specific Impella 5.5 set. Healthcare professionals should not use the affected controller unless the software is updated to v10.1 or above.