Micro Therapeutics recalls Apollo Onyx Delivery Microcatheter (AOMC) sold in US with European indications for use. This mismatch may cause incorrect medical procedures. Contact for details.
European version of microcatheter were distributed within US which contain a different "Indications for Use".
Micro Therapeutics recalls a specific type of medical catheter sold in the US that was distributed with European labeling instead of US labeling. This could lead to incorrect medical procedures if used without understanding the intended use.
The catheter was distributed in the US with European indications for use instead of US-approved labeling. This mismatch could lead to incorrect medical procedures if the healthcare provider uses it without understanding the intended use.
Healthcare professionals using the Apollo Onyx Delivery Microcatheter (AOMC) in the US. Patients receiving procedures with this catheter may be at risk if the labeling is incorrect.
Check for the UDI code 00763000311438 and lot numbers B510757, B593510, or B610689 on the catheter packaging. The catheter is designed for use with the Onyx liquid embolic system (LES).
Look for the UDI code 00763000311438 and lot numbers B510757, B593510, or B610689 on the catheter packaging.
The catheter was distributed in the US with European indications for use instead of US-approved labeling, which could lead to incorrect medical procedures.
Check for the UDI code 00763000311438 and lot numbers B510757, B593510, or B610689 on the packaging. If you have these, contact Micro Therapeutics for further instructions.
The recall is due to a labeling mismatch, not a physical hazard. There is no risk of serious injury from the catheter itself.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1252-2024 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-1252-2024 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.
