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.

Class II

Recalling firm: Micro Therapeutics, Inc.
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.
Affected products (lot / model / serial): Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
Units affected: 2
Distribution pattern: U.S. Nationwide distribution in the states of GA and TX.
Firm location: Irvine, CA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-3326-2026
Recall initiated: June 25, 2026
FDA classification date: September 28, 2026
FDA report date: October 7, 2026
FDA event ID: 99689
Last updated on HTM Vibe: October 13, 2026