Micro Therapeutics, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
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.
Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →