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FDAFDA · Food and drugs·Recall number Z-1252-2024

The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.

Published March 13, 2024 · Recall initiated: January 11, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

European version of microcatheter were distributed within US which contain a different "Indications for Use".

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Micro Therapeutics, Inc.
Distributor
US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, MA, MD, MI, MO, NC, ND, NE, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI.
Lot
UDI: 00763000311438/ Lot # B510757, B593510, B610689
Risk classification
Class II
Area (FDA)
device
Country
United States

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