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This is part of a larger recall. The most authoritative record is FDA-Device / Z-2773-2026.

FDA-Device2026-07-29Class IIMISBRANDING

Micro Therapeutics Pipeline Flex Embolization Device recalled for incorrect labeling

Micro Therapeutics
LABEL MIX UPNationwide distribution

Micro Therapeutics Pipeline Flex device recalled for mislabeled implant size

Micro Therapeutics embolization devices have incorrect labeling: units labeled as 3.0 mm x 20 mm actually contain 12 mm implants, and units labeled as 3.0 mm x 12 mm actually contain 20 mm implants. This mismatch could lead to implantation of the wrong device size. Six units were distributed across multiple states.

  • If you received or used a Pipeline Flex device from lot D062531, contact Micro Therapeutics or your healthcare provider immediately.
  • Do not use any affected devices until you confirm the actual implant size with the manufacturer or your medical team.
  • Report any adverse events to the FDA MedWatch program.
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
6 units
Manufactured in
9775 Toledo Way, N/A, Irvine, CA, United States
Products
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2774-2026

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