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Recalls & Safety AlertsVersion 6

FDA Records Class I Recall of Abiomed Impella CP Pump Sets Over Introducer Leak Risk

An FDA enforcement report covering 87,277 units cites potential introducer sheath leakage that the record says is not visually detectable by users.

By AI ReporterUpdated Aug 7, 2026, 10:49 a.m. ET
An FDA enforcement report, recall number , records a recall by of the ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing the ABIOMED Impella Introducer, 14 Fr, 13 cm and 25 cm, Product Code 0052-3046 (GTINs 00813502012279 and 00813502011876). The record covers and states that all current batches in the field are affected. The firm initiated the action on June 11, 2026, and the report date is July 22, 2026. The status is listed as , and this is a developing matter. The reason given in the enforcement report 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 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 product is described in the record as a heart pump and accessories. This is not a consumer product. Background material from the FDA and from clinical documentation describes the device as a sterile, single-use hospital kit built around a catheter with a tiny micro-axial, screw-type rotary pump at its tip, driven by an external console and a purge cassette that continuously flushes the catheter with rinsing fluid. The set under this code is the disposable portion: the pump catheter, the purge cassette, a 0.018-inch, 260 cm placement guidewire, and an introducer kit containing 14 French peel-away sheaths in 13 cm and 25 cm lengths with a hemostatic valve, plus 8, 10, 12 and 14 French dilators and a 0.035-inch guidewire. The peel-away introducer is an access sheath pushed through the skin into a blood vessel so the catheter can be threaded through it, then split and pulled away. The catheter is passed through an artery and positioned across the aortic valve so the pump can move blood from the left ventricle into the aorta. It is a prescription device regulated in the United States through FDA premarket approval, sold by part number to hospitals and used by clinicians in catheterisation labs and operating rooms; a member of the public cannot buy it. That background describes the device generally and says nothing about this recall. Distribution is listed as worldwide, including US nationwide and a list of named countries and territories: 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. The FDA defines as its most serious recall category, used where there is a reasonable probability that use of the product will cause serious harm or death. The agency's enforcement database records no other enforcement action by this firm; that history says nothing about fault in this action. The enforcement record does not state any reports of harm, and no cause beyond the manufacturing issues described in the record has been established.

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Revision history

  1. Version 67 Aug 2026, 14:49current

    No new facts; headline and dek added, body unchanged.

  2. Version 57 Aug 2026, 13:38

    Expanded the device-description paragraph with FDA and clinical-documentation detail on the pump set's contents (purge cassette, guidewires, dilators, peel-away sheath) and added the corresponding source URLs.

  3. Version 47 Aug 2026, 08:43

    Replaced the device description previously attributed to FDA premarket approval documents (including the Danvers, Massachusetts manufacturer address) with the sourced EuroIntervention description, and noted that available sources do not state materials or place of manufacture.

  4. Version 37 Aug 2026, 03:53

    Added a paragraph describing what the device is and who uses it, sourced to FDA premarket approval documents, with the manufacturer location in Danvers, Massachusetts.

  5. Version 26 Aug 2026, 23:52

    Removed the device-description paragraph sourced outside the fact set and listed the recall's distribution countries in full as given in the enforcement record.

  6. Version 16 Aug 2026, 18:49

    First published.

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