This is part of a larger recall. The most authoritative record is FDA-Device / Z-2773-2026.
Micro Therapeutics Pipeline Flex Embolization Device recalled for incorrect labeling
What this means
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.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2774-2026Want us to check the next one for you?
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