Abiomed recalled two units of the Impella 5.5 with SmartAssist on December 4, 2025. The devices were packaged in incorrect outer cartons, posing a potential hazard. Patients and healthcare providers must stop using the devices immediately.
Device packaged in incorrect outer box carton.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled products include the Impella 5.5 with SmartAssist, Catalog Number 1000482, and Australian Configuration Code 1000770. The affected units have serial numbers 621454 and 621455. They were distributed in Australia.
The devices were packaged in incorrect outer cartons, which may lead to misidentification and improper use. This could result in serious complications for patients relying on these devices.
There have been no reported injuries or incidents directly linked to this packaging error. The recall is classified as Class II due to the potential for high hazard.
Patients and healthcare providers should stop using the Impella 5.5 devices immediately. Contact Abiomed, Inc. or your healthcare provider for further instructions on the recall.
For more information, contact Abiomed at [insert contact number]. Additional details can be found on the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1030-2026.
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