Abiomed Class I Device Recall Z-1470-2026

FDA: Device Recalls Class I

Filed January 27th, 2026

Detected March 23rd, 2026

Summary

The FDA has announced a Class I device recall for Abiomed's Impella RP Flex with SmartAssist due to a malfunctioning differential pressure (dP) sensor. This recall impacts approximately 4,496 units distributed worldwide and is ongoing.

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What changed

The U.S. Food and Drug Administration (FDA) has classified a recall initiated by Abiomed, Inc. for their Impella RP Flex with SmartAssist device as Class I, the most serious category. The recall, identified by recall number Z-1470-2026, concerns approximately 4,496 units distributed globally. The reason for the recall is a potential malfunction of the differential pressure (dP) sensor, which could lead to inaccurate sensor values.

Healthcare providers using the Impella RP Flex device should be aware of this ongoing recall and assess its potential impact on patient care. While the recall is voluntary and firm-initiated, the Class I classification indicates a reasonable assurance that the use of, or exposure to, a defective product may cause serious adverse health consequences or death. Compliance officers should ensure that their organizations are aware of the recall status and any specific instructions provided by Abiomed regarding the affected devices.

What to do next

Review Abiomed's recall notification for Impella RP Flex with SmartAssist.
Assess patient safety implications if the affected device is in use.
Ensure awareness of the ongoing recall status.

Source document (simplified)

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