Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology
- Recalling company
- Micro Therapeutics, Inc.
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
- Reason
- Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 8, 2026
- Reported
- Jul 29, 2026
- Distribution
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
- Status
- Ongoing
- Quantity
- 6 units
- Lot / codes
- UDI: 00763000448844/ Lot: D062531
- Company location
- Irvine, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2774-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2774-2026 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.