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Micro Therapeutics, Inc.: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Devic

Medical DevicesSource: FDA (device) · Date: 2026-10-07

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Micro Therapeutics, Inc.
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.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution in the states of GA and TX.
Recall initiated
2026-06-25
Code info
Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
Product quantity
2
Voluntary mandated
Voluntary: Firm initiated
City
Irvine
State
CA
Country
United States
Event id
99689
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