FDA-Device2026-10-07Class IIMISBRANDING
Micro Therapeutics Pipeline Flex Embolization Device recalled for incorrect diameter labeling
What this means
Two units of the Micro Therapeutics Pipeline Flex Embolization Device (model PED2-300-12) were distributed with incorrect labeling. The packages were labeled as 3.00 mm diameter, but the devices inside were actually 2.50 mm diameter. This mismatch could lead to incorrect device selection during surgery.
- If you received this device (lot #D112860), do not use it and contact Micro Therapeutics immediately.
- Verify the actual device diameter matches the package label before any procedure.
- Report any use of an incorrectly labeled device to your distributor or Micro Therapeutics.
The agency's original wording
Hazard
Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
Intended for
Adults (22 years and older)
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of GA and TX.
Affected count
2
Manufactured in
9775 Toledo Way, Irvine, CA, United States
Products
Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield Technology implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires and indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3326-2026More Micro Therapeutics recalls
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