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 Impella 5.5 with SmartAssist is a cardiac assist device designed to support patients with severe heart conditions. It is commonly used in critical care settings to help maintain blood flow during high-risk procedures or recovery periods.
The incorrect packaging could lead to confusion about the device's intended use or application, potentially risking patient safety. This is particularly problematic in high-stakes medical environments.
This recall is not part of a broader industry pattern.
The recall may cause inconvenience and concern among patients and healthcare providers relying on the Impella 5.5 for critical care, emphasizing the importance of proper device handling and packaging.
The serial numbers and catalog numbers can typically be found on the device label or packaging.
Expect a timeline of 4-6 weeks for processing any refunds or replacements once the company is contacted.
Keep records of the recall notice, communications with the company, and any receipts or documentation related to the device.
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.
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