FDAFDA recall Z-2774-2026 · Jul 29, 2026
Micro Therapeutics, Inc.: Pipeline Flex Embolization Device with Shield Technology recall
Recall found
Product
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
Reason for recall
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
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: 00763000448844/ Lot: D062531
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
- Recalling firm
- Micro Therapeutics, Inc., Irvine, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-08
Source: openFDA enforcement record Z-2774-2026 · search recall number Z-2774-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.