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Recall Observatory FDA recall evidence

Device product

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

Z-2457-2026

May 18, 2026

Class I

Product summary

Firm
Abiomed, Inc.
Event
Event 98946
Status
Ongoing
Classification
Class I
Quantity
10 units
Official record key
device-enforcement:Z-2457-2026

Official wording

Reason: 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.

Code information: GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).

Distribution pattern: US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.