MICROVENTION INC. recalls LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers

Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.

On 5/29/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inform all individuals within your organization of the recall and forward the recall notice to any organizations that may have received the affected products. 2) Complete and return the customer acknowledgement form via email: recalls@microvention.com 3) If your institution has affected inventory call firm's Customer Care at 800-888-3786 or email tmccustomer.admin@terumomedical.com Please direct questions to the firm at MVEMEAQARA@microvention.com

• FDA enforcement recordOfficial FDA database entry for Z-2188-2025
• FDA 510(k) clearance · K150958The device's official FDA premarket clearance record
• FDA device classification · KRDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.3300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MICROVENTION 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.