RecallRadar
FDA · Medical devicesClass I

Abiomed, Inc. medical device recall: ABIOMED Impella RP Flex with SmartAssist Set

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
98893
Recall initiated
Jun 11, 2026
Classified by FDA
Jul 10, 2026
Posted in Enforcement Report
Jul 22, 2026
Recalling firm
Abiomed, Inc.
Firm location
Danvers, MA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
13

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jun 11, 2026. FDA classified it 29 days later, on Jul 10, 2026. This recall event covers 13 separate products, each with its own FDA recall number. Distribution reported by FDA: 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… Abiomed, Inc. has 31 recalls in our records.

Recalled products (13)

  • Z-2681-2026 Class I Ongoing

    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

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

    Quantity: 5,017 units

  • Z-2682-2026 Class I Ongoing

    ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories

    Codes / lots: Pump Set Code 0048-0003; Introducer Product Code 0052-3046. GTIN: 00813502012279, 00813502011876. All current batches in field.

    Quantity: 87,277 units

  • Z-2683-2026 Class I Ongoing

    ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories

    Codes / lots: Pump Set Code 1000550; Introducer Product Code 0052-3046. GTIN: 00813502013474. All current batches in field.

    Quantity: 846 units

  • Z-2684-2026 Class I Ongoing

    ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories

    Codes / lots: Pump Set Code 1000441; Introducer Product Code 2000342. GTIN: 00813502012910. All current batches in field.

    Quantity: 196 units

  • Z-2685-2026 Class I Ongoing

    ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories

    Codes / lots: Pump Set Code 0052-0038; Introducer Product Code 0052-3052. GTIN: 00813502011708, 00813502012729. All current batches in field.

    Quantity: 1,540 units

  • Z-2686-2026 Class I Ongoing

    ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories

    Codes / lots: Pump Set Code 0052-0039; Introducer Product Code 0052-3053. GTIN: 00813502011715, 00813502012736. All current batches in field.

    Quantity: 1,223 units

  • Z-2687-2026 Class I Ongoing

    ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories

    Codes / lots: Pump Set Codes 1000211, 1000212; Introducer Product Code 0052-3006-JP. GTIN: 00813502012453. All current batches in field.

    Quantity: 383 units

  • Z-2688-2026 Class I Ongoing

    ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories

    Codes / lots: Pump Set Codes 1000459, 1000460; Introducer Product Code 0052-3006-JP. GTIN: 00813502013054. All current batches in field.

    Quantity: 1,574 units

  • Z-2689-2026 Class I Ongoing

    ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories

    Codes / lots: Pump Set Code 0048-0014; Introducer Product Code 0052-3046. GTIN: 00813502012873, 00813502013344, 00813502013368, 04260113630280. All current batches in field.

    Quantity: 35,430 units

  • Z-2690-2026 Class I Ongoing

    ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories

    Codes / lots: Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field.

    Quantity: 8,382 units

  • Z-2691-2026 Class I Ongoing

    ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories

    Codes / lots: Pump Set Code 0048-0044; Introducer Product Code 0052-3046. GTIN: 00813502012200. All current batches in field.

    Quantity: 557 units

  • Z-2692-2026 Class I Ongoing

    ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories

    Codes / lots: Pump Set Code 0052-0011-JP; Introducer Product Code 0052-3006-JP. GTIN: 00813502011340. All current batches in field.

    Quantity: 117 units

  • Z-2693-2026 Class I Ongoing

    ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories

    Codes / lots: Pump Set Code 0052-0023-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011449. All current batches in field.

    Quantity: 96 units

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 98893
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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