FDA Device recall Z-2457-2026
Impella CP Set with SmartAssist
- FDA Device
- Class I
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class I recall of Impella CP Set with SmartAssist by Abiomed, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2457-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-18 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abiomed |
| Distribution | GA, IA, NE, PA, TX, WA, WI |
Product
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
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.
Identifiers
| code_info | GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525),…GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2457-2026%22
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