Abiomed, Inc. — Class I: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14
Abiomed, Inc. has initiated a Class I recall of the Impella CP Set (Pump Set Code 0048-0003) due to potential sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The FDA notes that these manufacturing defects are not visually detectable by the user prior to use.
Abiomed, Inc.; clinical users of Impella CP heart pumps; hospital supply chain managers; and regulatory, quality, and clinical departments involved in cardiovascular device management.
The Class I designation indicates that the FDA considers this a situation with a reasonable probability of serious adverse health consequences or death. Because the defect is not visually detectable, clinicians cannot mitigate the risk through pre-use inspection alone. This suggests a failure in manufacturing quality control or design validation regarding the integrity of the introducer hub and sheath cap. Regulatory professionals should view this as a significant post-market safety event requiring rigorous investigation into manufacturing tolerances and material integrity.
QA and clinical teams should identify and quarantine affected lots of Impella CP Sets (Code 0048-0003). Clinicians should be alerted that the sheath leakage issue is not visually detectable during preparation. Regulatory teams must ensure that the recall status is monitored and that CAPA processes address the underlying manufacturing defect in the hub score lines and sheath cap.
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 Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories. Firm: Abiomed, Inc. (Danvers MA United States). Status: Ongoing.
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