Micro Therapeutics recalls Apollo Onyx Delivery Microcatheter (AOMC) sold in US with different indications for use than European version. This may lead to improper medical use. Contact for details.
European version of microcatheter were distributed within US which contain a different "Indications for Use".
Micro Therapeutics is recalling a specific type of medical catheter sold in the US that has different intended medical uses than the European version. This could lead to improper medical procedures if used without understanding the correct indications.
The US version of the catheter has different intended medical uses compared to the European version. This difference could lead to improper medical procedures if the incorrect indications for use are followed, potentially causing complications.
Medical professionals who use the Apollo Onyx Delivery Microcatheter (AOMC) in the US may be affected. Patients receiving procedures with this catheter could be at risk if the incorrect indications for use are followed.
Check for the UDI code 00763000311445 and lot numbers B510758, B555761, B615024, B615025, B629693, B629694 on the catheter packaging or label.
Look for the UDI code 00763000311445 and lot numbers B510758, B555761, B615024, B615025, B629693, B629694 on the catheter packaging or label.
The US version of the Apollo Onyx Delivery Microcatheter has different intended medical uses than the European version, which could lead to improper procedures if the incorrect indications for use are followed.
Check the product label for the UDI code 00763000311445 and lot numbers B510758, B555761, B615024, B615025, B629693, B629694. If you have these, contact Micro Therapeutics for further instructions.
The recall is due to a difference in intended medical uses between the US and European versions, not a direct risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1253-2024 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-1253-2024 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.
