FDAHealthJune 8, 2026
Micro Therapeutics, Inc. — Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 8, 2026
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
What's affected?
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
- Lot code
- D062612
Additional details
UDI: 00763000448806/ Lot: D062612, D112860
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13 units.
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