Medical Device Recall: ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Abiomed, Inc. · June 11, 2026
Reason for Recall
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Distribution
Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
States Affected
NATIONWIDE
Quantity Affected
8,382 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2690-2026
Status: ongoing
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