Micro Therapeutics recalls 3.00 mm x 12 mm embolization devices due to incorrect labeling that may lead to wrong implant size being used 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 embolization devices for intracranial aneurysms because they are labeled incorrectly. This could lead to using the wrong implant size during surgery, which might cause complications.
The devices are labeled with incorrect dimensions. Devices labeled as 3.0 mm x 12 mm implants actually contain 20 mm implants, and devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants. This mismatch could lead to using the wrong size during surgery.
Patients who received the recalled embolization devices for intracranial aneurysms. Medical professionals using these devices during procedures are at risk if they rely on the labels.
Check the device label for the model number 027 REF PED2-300-12. The device is used for intracranial aneurysms and has a unique device identifier (UDI) of 00763000448806 and lot number D062612.
Look for the model number 027 REF PED2-300-12 on the device label.
The record does not specify the correct size; it only states that the labeling is incorrect.
Check the device label for the model number 027 REF PED2-300-12 and the unique device identifier (UDI) 00763000448806 with lot number D062612.
The recall does not specify a remedy, so no action is required beyond checking the label.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-2773-2026 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-2773-2026 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.
