Micro Therapeutics recalls Pipeline Flex Embolization Devices with incorrect labeling that may cause improper use in intracranial aneurysm treatment.
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.
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.
The devices have incorrect size labels that could lead to improper placement during treatment. Using the wrong size device might cause complications like vessel damage or ineffective treatment.
Patients who received the recalled devices during intracranial aneurysm treatment are most at risk. Healthcare providers using these devices for procedures are also affected.
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.
Check the device label for the model number and size specifications to confirm if it matches the recalled product.
The devices have incorrect labeling: those labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and those labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
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 recall does not specify a remedy, so contact Micro Therapeutics directly for guidance.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-2774-2026 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-2774-2026 from Micro Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
