OVERLOOKED

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Class IIOngoing

Micro Therapeutics, Inc. recalls 2 products

Recall date · record updated Jul 29, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Micro Therapeutics, Inc.
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99326…

Products (2)

  1. Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter

    Codes/lots: UDI: 00763000448806/ Lot: D062612Quantity: 11 unitsRecall no. Z-2773-2026Class II

  2. Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter

    Codes/lots: UDI: 00763000448844/ Lot: D062531Quantity: 6 unitsRecall no. Z-2774-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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