FDAFDA · Food and drugs·Recall number Z-2773-2026
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Published July 29, 2026 · Recall initiated: June 8, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Micro Therapeutics, Inc.
- Distributor
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
- Lot
- UDI: 00763000448806/ Lot: D062612
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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