FDA
Food and Drug Administration · Recall Z-2457-2026 · May 18, 2026Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Abiomed, Inc.
The 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. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 672986Model 673252Model 644591Model 645428Model 644314Model 613525)Model 1000851 (636173)Model 0048-0014 (499250)Model 0048-0024-JP (661216).UPC 00813502012279Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.