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🇨🇦 Automated Impella Controller

Recall date: February 25, 2026Country: CACategory: medical_devices
Hazard/Reason: Abiomed has identified that Automated Impella Controller (AICS) with software V8.2.3, when used in conjunction with an Impella 5.5 with smart assist set (product code 0550-0004), has a delayed "purge system blocked" alarm. Software versions post-v10.1 have this issue addressed.  Abiomed recommends that you do not use the AIC with an Impella 5.5 with smart assist set (product code 0550-0004) unless AIC software is updated to v10.1 or above.
This page links to official sources. Verify model/lot/batch details in the official notice.