Abiomed recalled 9,177 Automated Impella Controllers on September 16, 2025. The recall follows reports of purge pressure issues due to purge retainer failures. Patients and healthcare providers must stop using the devices immediately.
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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
The recall affects several models of the Automated Impella Controller with product codes including 1000432 and 0042-0000-US. These devices were distributed worldwide, including in the US, Canada, and Europe, between 2023 and 2025.
The Automated Impella Controller may experience purge pressure issues due to failures in the purge retainer. This defect can lead to serious complications during its use.
The recall is classified as Class I, indicating a high risk of injury. As of now, there are no reported injuries or deaths associated with this recall.
Healthcare providers and patients should stop using the recalled devices immediately. They should contact Abiomed, Inc. or their healthcare provider for further instructions.
For more details, consumers can contact Abiomed at 1-800-422-8666 or visit their website at www.abiomed.com.
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