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High severity

Impella RP. Product Code: 0046-0011.

SourceFDA Device Enforcement
CategoryMedical Device
SeverityHigh
Statusongoing
Recall dateJanuary 27, 2026
ReportedMarch 11, 2026
Recalling firmAbiomed, Inc.
Country / regionUnited States MA

Hazard

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

Affected products

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