United StatesPipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm (REF PED2-300-12) and 3.00 mm x 20 mm (REF PED2-300-20) intracranial aneurysm flow diverters are affected; devices labeled 3.0 mm x 20 mm may contain 12 mm implants and devices labeled 3.0 mm x 12 mm may contain 20 mm implants. Micro Therapeutics, Inc. recalled the devices because of incorrect labeling; the units were distributed in CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, and WA.
What's being recalled
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
Recalling firm: Micro Therapeutics, Inc., Irvine, CA, United States.
How to identify it
UDI: 00763000448806/ Lot: D062612 UDI: 00763000448844/ Lot: D062531
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)