Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: recall status
Notice names this product. Micro Therapeutics’s Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code is named in FDA Class II recall Z-3326-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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. Identifying details: Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860. Units affected: 2. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
Distribution
U.S. Nationwide distribution in the states of GA and TX.
Agency product description and boundaries
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.