Abiomed, Inc. recalls ABIOMED Impella RP Flex with SmartAssist Set

Recalling company

Abiomed, Inc.

Product

ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories

Reason

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Jun 11, 2026

Reported

Jul 22, 2026

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).

Status

Ongoing

Quantity

5,017 units

Lot / codes

Pump Set Code 1000323; introducer Product Code 2000342. GTIN 00813502012811. All current batches in field.

Company location

Danvers, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2681-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2681-2026 in the FDA Enforcement Report. Also see FDA recall press releases.