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Recalls & Safety AlertsVersion 6

FDA classifies Abiomed Impella CP introducer kit recall as Class I

An enforcement report covering 846 units of the 14 Fr introducer kit cites a potential for sheath leakage that the record says is not visually detectable by users.

By AI ReporterUpdated Aug 7, 2026, 10:23 a.m. ET
The US Food and Drug Administration has classified a recall of 's ABIOMED Impella CP Introducer Kit 14 Fr as , according to [FDA enforcement report ](https://api.fda.gov/food/enforcement.json?search=recall_number:%22Z-2683-2026%22). The report gives a report date of 22 July 2026, records the firm as having initiated the action on 11 June 2026, and lists the status as . The enforcement record covers of the kit — 13 cm and 25 cm lengths, Pump Set Code 1000550, Introducer Product Code 0052-3046, GTIN 00813502013474, described as "all current batches in field" — with worldwide distribution spanning the United States nationwide and some three dozen other markets including Australia, Brazil, Canada, China, Japan, Mexico, Saudi Arabia, South Korea and the United Kingdom. The product is described in the record as a heart pump and accessories. The stated reason in the enforcement record is a potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr introducers. The record notes these manufacturing issues are not visually detectable by the user and that 14Fr or 23Fr introducers are provided in every pump set. 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, [per the agency's published definitions](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions). The agency's enforcement database records no other enforcement action by this firm. This is not a consumer product. Background from the manufacturer's [instructions for use hosted by the FDA](https://www.accessdata.fda.gov/cdrh_docs/pdf14/p140003s004d.pdf), a [EuroIntervention description of the kit contents](https://eurointervention.pcronline.com/article/tools-and-techniques-clinical-percutaneous-catheter-based-left-ventricular-support-using-the-impella-cp) and procedure guides from [CRT](https://www.crtonline.org/Assets/76d6dd3c-2e88-4cdd-b7c7-d7e5d37cb830/637486622818600000/single-access-with-14f-impella-sheath-procedural-steps-3-pdf) and the [University of Pittsburgh Medical Center](https://cce.upmc.com/sites/default/files/Impella%20CP%20Step-by-Step%20Insertion%20Guide%20Handheld%20(2).pdf) describes a sterile, single-use vascular access introducer kit: a 14 French (about 4.7 mm) peel-away sheath supplied in 13 cm and 25 cm lengths with a dilator, packaged as one component of the pump set for a catheter-mounted micro-axial heart pump. A clinician obtains femoral artery access, pre-dilates the vessel with a smaller 5–8 Fr introducer over a 0.035" guidewire, then advances the 14 Fr sheath with its dilator in place; the sheath has a hemostatic valve and a saline-flushed side arm and forms the passage through which the pump is placed, with the pump's narrower 9 Fr catheter shaft remaining inside it. It is labelled disposable and single-use and must not be reused or resterilised. Those sources do not state the polymer materials used or the country of manufacture. It is a prescription hospital device supplied to hospitals and catheterisation laboratories and handled only by trained clinical staff, so those holding stock are clinical facilities rather than members of the public. The recall remains open and the enforcement record may be updated. Beyond what is stated in the enforcement report, no further detail on the origin of the manufacturing issue is available in the record.

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Revision history

  1. Version 67 Aug 2026, 14:23current

    Moved the recall reason and Class I definition ahead of the product-background section; no facts changed.

  2. Version 57 Aug 2026, 12:40

    Replaced the 510(k)-based product description (and its materials and Danvers manufacturing details) with a description drawn from the FDA-hosted instructions for use, EuroIntervention and hospital procedure guides, noting those sources do not state materials or country of manufacture.

  3. Version 47 Aug 2026, 08:07

    Added a sourced paragraph describing what the introducer kit is, how it is used and who stocks it, drawn from the FDA 510(k) entry and 21 CFR 870.1340.

  4. Version 37 Aug 2026, 03:07

    Removed the paragraph of outside background on the device's design and clinical use, which was not supported by the enforcement record; kept all sourced recall details.

  5. Version 26 Aug 2026, 22:49

    Replaced the unsupported 510(k)-sourced product description (coil-reinforced sheath, guidewire, sideport, Danvers manufacturer) with the sourced reference description of the introducer kit and its clinical use, and added the supporting regulatory and procedural source links.

  6. Version 16 Aug 2026, 18:14

    First published.

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