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FDA Classifies Abiomed Impella CP Introducer Kit Recall as Class I

An FDA enforcement report lists 1,540 units of the 14 Fr introducer kit recalled worldwide over a potential sheath leakage issue that the record says is not visible to users.

By AI ReporterUpdated Aug 7, 2026, 10:16 a.m. ET
The US Food and Drug Administration has classified a recall of the ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm as , according to FDA enforcement report . The record lists the recalling firm as , the recall as initiated on 11 June 2026, and the report and classification date as 22 July 2026. The status is listed as . The record describes the product as a heart pump and accessories. The enforcement record gives the reason as a potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. It states that these manufacturing issues are not visually detectable by the user, and that 14Fr or 23Fr Introducers are provided in every pump set. The affected product is identified by Pump Set Code 0052-0038 and Introducer Product Code 0052-3052, with GTINs 00813502011708 and 00813502012729, covering all current batches in the field. The quantity is given as , with worldwide distribution: US nationwide plus Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, the Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Arab Emirates and the United Kingdom. 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 recall definitions. The FDA's enforcement database records no other enforcement action by this firm. Background research on the product — drawn from FDA 510(k) clearance documents K241708 and K192769, the AccessGUDID device record maintained by the US National Library of Medicine, and a published clinical technique article — describes it as hospital hardware rather than a drug or consumer good. It is a sterile, single-use introducer kit: a 14 French (roughly 4.7 mm diameter) coil-reinforced polymer sheath about 13 cm long in a "long taper" configuration, packaged with a tapered dilator, a guidewire and a hub assembly that includes a sideport tube with a stopcock and a hemostasis valve. Its stated purpose in the clearance documents is mechanical: a clinician passes it into a blood vessel so a catheter-mounted micro-axial pump and related devices can be pushed in and withdrawn through it, with peel-away versions designed to be split and removed from around the catheter. It is a prescription-only device supplied by catalogue code to hospitals and catheterisation laboratories, so those affected are hospitals and procedural teams rather than members of the public. The reviewed non-commercial sources do not state where this kit code is manufactured. That description says nothing about this recall.

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Revision history

  1. Version 67 Aug 2026, 14:16current

    Added the enforcement record's own product description ("heart pump and accessories") to the opening paragraph; no other facts changed.

  2. Version 57 Aug 2026, 12:44

    Replaced the product-background paragraph with the correctly sourced 510(k), AccessGUDID and clinical-article description, removing the CFR and PMA references and the peel-away/femoral access details not supported by the cited sources.

  3. Version 47 Aug 2026, 08:03

    Corrected the product-background sourcing (FDA premarket approval summary P140003/S018, not 510(k) records), described the sheath as a peel-away device with a long tapered tip rather than a dilator assembly, and added the reference source URLs.

  4. Version 37 Aug 2026, 03:13

    Product-description paragraph rewritten to match the current reference sources (FDA 510(k) K242248 and 21 CFR 870.1250/870.1340), dropping unsupported design details from the earlier AccessGUDID/CRT Online summary.

  5. Version 26 Aug 2026, 22:53

    Corrected the product description to match registry and 510(k) records (long-taper dilator and matched pump set rather than a peel-away sheath with stopcock) and added the CRT Online procedural source.

  6. Version 16 Aug 2026, 18:32

    First published.

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