Pipeline Flex Embolization Device with Shield Technology recall
Micro Therapeutics, Inc. recalled Pipeline Flex Embolization Device with Shield Technology on July 29, 2026 because of 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. It was sold nationwide.
Why it was recalled
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's recalled
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
Quantity: 6 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Micro Therapeutics, Inc., Irvine, CA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA. - Status
- Ongoing
- Recall number
- Z-2774-2026
- Source
- U.S. Food and Drug Administration
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