Automated Impella Controller (AIC)
OFFICIAL-SOURCE RECALL · CANADA
Automated Impella Controller (AIC) Recall: based strategy for component replacement will be
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryCanadaPublishedAugust 27, 2026Last updatedAugust 27, 2026Official source last checkedAugust 27, 2026 at 5:01 PM UTC
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Is your product affected?
- Brand
- See official notice
- Product
- Automated Impella Controller (AIC)
- Manufacturer
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- Serial number / range
- number
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
based strategy for component replacement will be implemented. The purge flag is the component that engages with the purge disc and allows the AIC to recognize the purge disc. These AIC purge flag component failures may result most frequently in user inconvenience due to troubleshooting, attempted purge cassette exchange and AIC exchange. If the failure occurs before initiation of support, exposure may result in a delay to procedure, which is expected to remain clinically manageable in most cases. In the case of an urgent need for mechanical circulatory support or if the failure occurs during active Impella support, exposure may result in a temporary period of inadequate hemodynamic support during controller transition. Additional information Details Original
Hazard
based strategy for component replacement will be implemented. The purge flag is the component that engages with the purge disc and allows the AIC to recognize the purge disc. These AIC purge flag component failures may result most frequently in user inconvenience due to troubleshooting, attempted purge cassette exchange and AIC exchange. If the failure occurs before initiation of support, exposure may result in a delay to procedure, which is expected to remain clinically manageable in most cases. In the case of an urgent need for mechanical circulatory support or if the failure occurs during active Impella support, exposure may result in a temporary period of inadequate hemodynamic support during controller transition. Additional information Details Original
Official recall notice
Automated Impella Controller (AIC)
Agency: Health Canada
Official publication date: August 27, 2026
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