FDA DeviceClass INotable
FDA Recall: Impella RP with SmartAssist. Product Code: 0046-0035.
Description
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Remedy
291 units
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