FDA-Device2026-07-29Class IIMISBRANDING
Micro Therapeutics Pipeline Flex Embolization Device recalled for incorrect labeling
LABEL MIX UPNationwide distribution
Micro Therapeutics embolization devices recalled for incorrect labeling
Micro Therapeutics Pipeline Flex Embolization Devices have incorrect labeling on some units. Devices labeled as 3.0 mm x 20 mm actually contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm actually contain 20 mm implants. This mismatch could lead to incorrect implant selection during surgery.
- If your facility received affected lot numbers D062612 or D112860, verify the actual implant length before use.
- Contact Micro Therapeutics, Inc. for replacement devices or further guidance.
- Check with your surgical team or interventional radiology department if this device was used in your care.
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.
Sold states
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Affected count
13 units
Manufactured in
9775 Toledo Way, N/A, Irvine, CA, United States
Products
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2773-2026Also reported as
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