Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code:…

Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

On 06/25/2026, an "URGENT: MEDICAL DEVICE RECALL" letter was sent to customers to inform them that, Medtronic has confirmed a labeling error involving implant diameter in the affected lot. Devices from Lot # D112860 labeled as PED2-300-12 (3.00 mm diameter, 12 mm length) contain 2.50 mm diameter implants instead of the labeled 3.00 mm diameter. Customers are instructed to: 1. Do NOT use any impacted Pipeline Flex Embolization Device with Shield Technology devices listed. Remove and quarantine all unused impacted product units in their inventory. 2. Return the impacted product(s) to Medtronic. Their Medtronic representative can assist in facilitating the return of product and/or identifying suitable replacement product as necessary. 3. Complete the attached Customer Confirmation Form and email it to neuro.quality@medtronic.com. 4. Review their records to identify any patients who may have been treated with devices from the affected lot and assess whether any follow-up is appropriate. 5. Share this recall communication within their organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Maintain a copy of this letter for their records and the records of their patients with Pipeline Shield. For questions - contact Medtronic at 1 (800) 633-8766 or (763) 514-4000 (Worldwide) or Email: rs.nvquality@medtronic.com

• FDA enforcement recordOfficial FDA database entry for Z-3326-2026
• FDA device classification · OUTOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Micro Therapeutics, 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.