Abiomed recalled 291 Impella RP with SmartAssist devices sold worldwide, including the US. A differential pressure sensor may malfunction and cause readings to drift. Patients and healthcare providers should 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 with SmartAssist is a percutaneous right heart pump designed to support the right ventricle in patients with cardiac impairment. It is distributed worldwide and intended for professional medical use.
A malfunctioning differential pressure sensor can produce drift in readings, potentially compromising device performance and patient monitoring.
This recall is not described as part of a broader industry pattern.
For patients with the device, the recall requires immediate cessation of use and coordination with clinicians to assess replacement or monitoring needs.
Device labels include Product Code and UDI; recall details are on the FDA recall page for Z-1469-2026
Recall notice by letter; follow manufacturer guidance for remediation
Keep recall letter, device labeling, UDI, serial numbers, clinician notes, and correspondence with the manufacturer for records.
Product: Impella RP with SmartAssist. Product Code: 0046-0035. UDI-DI: 00813502011869. Quantity recalled: 291 units. Distribution: Worldwide including US nationwide and the listed countries. Recall date: 2026-01-27. Brand: Abiomed.
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