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FDA Records Class I Recall of 355 Abiomed Impella Introducer Kits Over Potential Sheath Leaks

An FDA enforcement report lists an ongoing Class I recall by Oscor Inc. of an Impella introducer kit distributed in Massachusetts, initiated June 10, 2026.

By AI ReporterUpdated Aug 7, 2026, 11:33 a.m. ET
An FDA enforcement report, recall number , records an recall of the Abiomed REF 0052-3025 Introducer Kit for Impella — a hemostatic peel-away introducer system with infusion sideport, 14F 13cm and 25cm — described in the record as heart pump and accessories. The recalling firm is listed as The record gives the initiation date as June 10, 2026 and the report date as July 22, 2026, with a quantity of and distribution in the US state of Massachusetts. The affected product is identified as all lots within expiry, GTIN 00885672009793 and 00813502010664. The reason given in the enforcement report is that, The record's product description names only a 14F size, while the stated reason refers to 14Fr and 23Fr sheaths; the record is quoted here as it stands. The kit is not a consumer product. Under the FDA's device classification at 21 CFR 870.1340, a catheter introducer is "a sheath used to facilitate placing a catheter through the skin into a vein or artery." It is a sterile, single-use, prescription-only Class II device: a thin plastic sheath, here 14 French in diameter and offered in 13 cm and 25 cm lengths, with a hemostatic self-sealing valve and a side port on the hub through which fluid can be infused. "Peel-away" means the sheath body is designed to split lengthwise so it can be stripped off after the device it carried is in place. Kits of this general type are shipped as sealed single-patient packs, typically containing the sheath and a matching dilator with associated accessories, and are sold by manufacturers and distributors directly to hospitals and cardiac catheterisation labs, where they are handled only by clinical staff. No member of the public would buy or hold one. is the FDA's most serious recall category, used where there is a reasonable probability that using the product will cause serious harm or death, according to the agency's published definitions. The status of this action is listed as , and the enforcement record may be updated as the recall proceeds. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action. The enforcement report does not describe any reported injuries.

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Revision history

  1. Version 67 Aug 2026, 15:33current

    No new facts in the record; headline and dek added and source list completed, story text otherwise unchanged.

  2. Version 57 Aug 2026, 12:31

    Removed unsupported device details (millimetre conversion, polyurethane construction, needle and guidewire contents) not present in the fact set and restated the kit description strictly from the cited regulatory and background sources.

  3. Version 47 Aug 2026, 08:18

    Product-description paragraph re-sourced to the FDA classification regulation (21 CFR 870.1340) and 510(k) summaries in place of the AccessGUDID/P140003 attribution, and a note added that the record names 14F in the description but 14Fr and 23Fr in the stated reason.

  4. Version 37 Aug 2026, 02:58

    Added a sourced paragraph describing what the introducer kit is and how it is supplied and used, citing AccessGUDID and FDA premarket approval summaries.

  5. Version 26 Aug 2026, 22:39

    No new facts; headline and dek added and wording of the recall summary tightened.

  6. Version 16 Aug 2026, 17:54

    First published.

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