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MEDICAL DEVICE RECALLMODERATE
Pipeline Flex Embolization Device with Shield Technology
Micro Therapeutics recalls Pipeline Flex Embolization Device due to incorrect labeling of implant sizes.
What to do
Check the device labeling and contact Micro Therapeutics for return or replacement.
Why it was recalled
Micro Therapeutics is recalling Pipeline Flex Embolization Device with Shield Technology due to incorrect labeling. 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.
Is mine affected?
This recall covers the products below. If you have any of them, yours is affected.
| Product |
|---|
| Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12 |
| Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20 |
Official source
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Editorial summary by Recall Canary · last updated 2026-07-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification