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Can cause harm that is usually temporary.

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter

Check the device or its packaging for

UDI: 00763000448844/ Lot: D062531

Why: 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.
Distributed: US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Company: Micro Therapeutics, Inc.
Announced: 29 July 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 8 June 2026

Source: FDA record Z-2774-2026 · retrieved 22 July 2026

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