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MEDICAL DEVICE RECALLCRITICAL
Impella RP Flex with SmartAssist
Abiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
What to do
Do not use the affected Impella RP Flex with SmartAssist devices. Contact Abiomed for instructions on returning the device and obtaining a replacement.
Why it was recalled
Abiomed is recalling the Impella RP Flex with SmartAssist (Product Code 1000323) because the differential pressure sensor may drift, leading to inaccurate readings and potential patient harm.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Impella RP Flex with SmartAssist. Product Code: 1000323. | 00813502012811 | Z-1470-2026 |
| Impella RP. Product Code: 0046-0011. | 04260113630273 | Z-1471-2026 |
| Impella RP with SmartAssist. Product Code: 0046-0035. | 00813502011869 | Z-1469-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · last updated 2026-07-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification