Official recall notice

FDA DeviceClass INotable

FDA Recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Recall date
2026-06-24
FDA class
Class I

Why it was recalled

Hazard

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Recommended action

What to do

10 units

Product description

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Verify with the official notice →
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