Abiomed, Inc. recalls Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…

Potential for thrombus formation during prolonged use of the introducer.

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

Abiomed notified consignees on about 05/22/2026, via letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were made aware of the issue and that if thrombus formation were to occur, the user may encounter difficulty aspirating the sheath sidearm or valve and may observe thrombus in the syringe or sidearm post aspiration or around the valve post CP pump removal. They were instructed to review inventory for affected units and quarantine them, arrange for their return using the provided shipment label from Sedgwick, and complete and return the provided business response form. Consignees were also instructed to forward the notification to anyone in the facility that needs to be informed, if any of the subject products have been forwarded to another facility, contact that facility and provide them with the notification, and to post a copy of the notification in a visible area for awareness.

• FDA enforcement recordOfficial FDA database entry for Z-2600-2026
• FDA 510(k) clearance · K241708The 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.