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FDA-Device2026-07-22Class IPACKAGING DEFECT

Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk

Abiomed
OTHERNationwide distribution

Abiomed Impella CP heart pump recalled for sheath leakage risk

Abiomed has recalled its Impella CP Smart Assist Set heart pump due to a potential leak in the introducer sheath (a thin tube used during insertion). The leak can occur under the sheath cap or along seam lines in certain models, but the defect is not visible to the user. All current batches worldwide are affected.

  • If you have an Impella CP Smart Assist Set, contact Abiomed or your healthcare provider immediately for instructions.
  • Do not use the affected pump set until you receive guidance from your medical team.
Hazard

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.

Sold states
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).
Affected count
8,382 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2690-2026

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