⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-06-24

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Abiomed, Inc.
Product
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Reason / 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.
Classification
Class I
Status
Ongoing
Distribution / sold at
US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
Recall initiated
2026-05-18
Code info
GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
Product quantity
10 units
Voluntary mandated
Voluntary: Firm initiated
City
Danvers
State
MA
Country
United States
Event id
98946
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