Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12
- Recalling company
- 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
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jun 25, 2026
- Reported
- Oct 7, 2026
- Distribution
- U.S. Nationwide distribution in the states of GA and TX.
- Status
- Ongoing
- Quantity
- 2
- Lot / codes
- Product/Catalog Number: PED2-300-12 UDI-DI/GTIN: 00763000448806 Lot Number: #D112860
- Company location
- Irvine, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3326-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3326-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.