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FDAClass I · Medical device · Recalled June 24, 2026
Impella CP Set with SmartAssist recall — Abiomed, Inc.
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.
Class I: most serious — reasonable probability of serious health consequences or death.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2457-2026
- Brand
- Abiomed
- Classification
- Class I
- Units affected
- 10 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Affected products
Companies & origin
- Recalling firm location
- Danvers, MA, United States
- Firm address
- 22 Cherry Hill Dr, 01923-2575
Identifying details (verbatim from the notice)
- Product codes / lots
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
- Distribution
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- Firm notified the public via
- Letter
- FDA event ID
- 98946
- Recall initiated
- May 18, 2026
- FDA classified
- June 18, 2026
- FDA report date
- June 24, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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