Abiomed, Inc. recalls ABIOMED Impella CP Set

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.

An URGENT MEDICAL DEVICE RECALL (CORRECTION) notice dated 06/10/2026 was mailed to consignees. The notice directs consignees to maintain awareness of this recall among practitioners and use appropriate clinical awareness, monitoring, and patient support as needed. Further clinical direction is provided in the notice. The notification is to be forwarded to users and to facilities where product was further distributed. The notice should be visible for awareness. Consignees with any questions can contact OneMD-Field_Actions@its.jnj.com.

• FDA enforcement recordOfficial FDA database entry for Z-2682-2026
• FDA 510(k) clearance · K192769The device's official FDA premarket clearance record
• FDA 510(k) clearance · K201116The device's official FDA premarket clearance record
• FDA device classification · DYBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1340The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Abiomed, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.