Abiomed, Inc. — Class I: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 1
Abiomed, Inc. has initiated a Class I recall for the Impella CP Introducer Kit 14 Fr due to a potential for sheath leakage under the cap and along hub score lines. The issue affects both 14Fr and 23Fr introducers, which are included in every pump set and possess manufacturing defects that are not visually detectable by the user.
This recall affects Abiomed, Inc., clinical staff utilizing Impella CP heart pump systems, hospital inventory managers, and regulatory/quality departments responsible for mechanical circulatory support devices.
A Class I designation indicates the FDA's assessment of a high risk for serious adverse health consequences or death. The fact that the defect is not visually detectable suggests a significant challenge for point-of-use mitigation, likely requiring a full removal or replacement of affected lots. Regulatory teams may need to investigate manufacturing process controls and supplier quality related to the hub score lines and sheath cap assembly.
QA teams should immediately verify inventory for the specified pump set codes and assess the adequacy of current visual inspection protocols, as the source indicates these defects are not visually detectable by users. Regulatory departments should update risk files to account for potential sheath leakage and ensure documentation meets Class I recall reporting requirements.
Class I. Reason: 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.. Product: 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. Firm: Abiomed, Inc. (Danvers MA United States). Status: Ongoing.
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