Automated Impella Controller (AIC)
OFFICIAL-SOURCE RECALL · AUSTRALIA
Automated Impella Controller (AIC) Recall: Classification Class I Reason for the Action Abiomed
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryAustraliaPublishedAugust 21, 2026Last updatedAugust 21, 2026Official source last checkedAugust 26, 2026 at 7:44 PM UTC
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- See official notice
- Product
- Automated Impella Controller (AIC)
- Manufacturer
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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
Classification Class I Reason for the Action Abiomed has identified an increase in complaints due to purge cassette recognition problems resulting from failures of the purge flag component within the purge pressure sensor assembly. The purge flag engages with the purge disc and allows the AIC to recognise that the purge disc is inserted properly. These failures require an AIC exchange to solve the problem. There have been reports of 37 serious injuries and 3 deaths associated with this problem. Instructions for Customers/Users Hospital inventory can continue to be used to ensure continuity of care. Abiomed is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC. Abiomed’s field service team will
Hazard
Classification Class I Reason for the Action Abiomed has identified an increase in complaints due to purge cassette recognition problems resulting from failures of the purge flag component within the purge pressure sensor assembly. The purge flag engages with the purge disc and allows the AIC to recognise that the purge disc is inserted properly. These failures require an AIC exchange to solve the problem. There have been reports of 37 serious injuries and 3 deaths associated with this problem. Instructions for Customers/Users Hospital inventory can continue to be used to ensure continuity of care. Abiomed is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC. Abiomed’s field service team will
Official recall notice
Automated Impella Controller (AIC)
Agency: Therapeutic Goods Administration
Official publication date: August 21, 2026
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