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.
✎ GovInfoNow plain-language explainer
Micro Therapeutics recalls certain Pipeline Flex Embolization Devices due to incorrect labeling. Devices labeled as 3.0 mm x 20 mm implants actually contain 12 mm implants, and those labeled as 3.0 mm x 12 mm implants contain 20 mm implants. This could lead to improper treatment if used without correction. Read more at govinfonow.com/recall/127822-micro-therapeutics-pipeline-flex-embolization-device-incorrect-labeling-risk.
“Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/127822-micro-therapeutics-pipeline-flex-embolization-device-incorrect-labeling-risk. Based on FDA recall #Z-2774-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2774-2026%22&limit=1).
The FDA announced on June 8, 2026, that Micro Therapeutics, Inc. is recalling the Pipeline Flex Embolization Device with Shield Technology due to incorrect labeling hazards. The recall involves devices where the labeled dimensions do not match the actual implant size.
How to tell if you have it
Brand: Micro Therapeutics
Product: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
UDI: 00763000448844
Lot: D062531
Quantity: 6 units
The hazard
According to the FDA, 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.
Context
GovInfoNow's records show Micro Therapeutics, Inc. has 6 other recalls on record since July 13, 2021. Other recent recalls of similar products include EMPOWR 3D KNEE Implants Have Incorrect Labeling (Jan. 15, 2026), Centinel Prodisc C SK U.S. Implant Extra Large 5mm - Labeling Mixup Recall (March 20, 2026), and W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall: Incorrect Labeling Risk (May 22, 2026).
How to tell if you have this one
Check for the product name 'Pipeline Flex Embolization Device with Shield Technology' and the model number 3.00 mm x 20 mm 027 REF PED2-300-20. The device was used for intracranial aneurysm treatment.
Brand
Micro Therapeutics
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Recall number
Product, codes & lots
Quantity
Z-2773-2026
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter; UDI: 00763000448806/ Lot: D062612
11 units
Z-2774-2026
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter; UDI: 00763000448844/ Lot: D062531
6 units
Based on the official FDA remedy
What to do — step by step
Verify Device Label
Check the device label for the model number and size specifications to confirm if it matches the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Delaware, Indiana, Massachusetts, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2774-2026 (June 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2774-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.