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Recall Observatory FDA recall evidence

Device product

Impella RP. Product Code: 0046-0011.

Z-1471-2026

January 27, 2026

Class I

Product summary

Firm
Abiomed, Inc.
Event
Event 98276
Status
Ongoing
Classification
Class I
Quantity
179 units
Official record key
device-enforcement:Z-1471-2026

Official wording

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

Code information: Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.

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.