Abiomed recalled 4,496 Impella RP Flex with SmartAssist devices. The recall cites a differential pressure sensor that may malfunction and drift readings. Stop using the device immediately and follow the manufacturer's recall instructions.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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 RP Flex with SmartAssist is a percutaneous right ventricular assist device used to support patients with severe heart failure. It provides short-term circulatory support via catheter-based therapy.
A malfunctioning differential pressure sensor can drift readings, potentially impairing device function and patient management.
This recall is not described as part of a broader industry pattern in the notice.
The recall affects patient safety and may require urgent medical decision-making. Healthcare providers must assess device status and communicate replacement options.
FDA recall page and Abiomed communications; manufacturer contact
Remedy timeline not specified; coordinate with Abiomed for replacement or remediation timelines
Keep recall letter, device serial numbers, model numbers, and all correspondence with Abiomed or clinicians
Product Code: 1000323 UDI-DI: 00813502012811 Distribution: Worldwide, including US nationwide and Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland Units recalled: 4,496 Recall date: 2026-01-27 Manufacturer: Abiomed, Inc.
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