Class 2 Device Recall Pipeline Flex Embolization Device with Shield Technology

• Date Initiated by Firm: June 08, 2026
• Date Posted: July 22, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2774-2026
• Recall Event ID: 99326
• PMA Number: P100018S026
• Product Classification: Intracranial aneurysm flow diverter - Product Code OUT
• Product: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
• Code Information: UDI: 00763000448844/ Lot: D062531
• 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: Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
• FDA Determined Cause: Labeling Change Control
• Action: On June 25, 2026, Medtronic (parent company of Micro Therapeutics) issued a Urgent Medical Device Expansion to affected consignees via visit. The revised notification included additional lots of product. The initial notification was issued on June 4, 2026 via visit. Medtronic ask consignees to take the following actions: 1. Do NOT use any impacted Pipeline Shield products. Remove and quarantine all unused impacted product units in your inventory. 2. Return the impacted product(s) to Medtronic. Your 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. Please share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. 5. Please maintain a copy of this letter for your records and the records of your patients with Pipeline Shield.
• Quantity in Commerce: 6 units
• Distribution: US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
• 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