Class 2 Device Recall Pipeline Flex Embolization Device with Shield Technology

• Date Initiated by Firm: June 25, 2026
• Date Posted: September 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3326-2026
• Recall Event ID: 99689
• PMA Number: P100018S026
• Product Classification: Intracranial aneurysm flow diverter - Product Code OUT
• Product: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield Technology implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires and indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
• Code Information: Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
• FEI Number: 1000220862
• Recalling Firm/ Manufacturer: Micro Therapeutics, Inc.; 9775 Toledo Way; Irvine CA 92618-1811
• For Additional Information Contact: Erika Winkels; 949-837-3700
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 2
• Distribution: U.S. Nationwide distribution in the states of GA and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OUT