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Recall Observatory FDA recall evidence

Device product

Impella RP Flex with SmartAssist. Product Code: 1000323.

Z-1470-2026

January 27, 2026

Class I

Product summary

Firm
Abiomed, Inc.
Event
Event 98276
Status
Ongoing
Classification
Class I
Quantity
4,496 units
Official record key
device-enforcement:Z-1470-2026

Official wording

Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Code information: Product Code: 1000323. UDI-DI: 00813502012811.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.