Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible Recalled by Micro Therapeutics, Inc. Due to European version of microcatheter were distributed within US...

Date: January 11, 2024
Company: Micro Therapeutics, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Micro Therapeutics, Inc. directly.

Affected Products

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.

Quantity: 82 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Micro Therapeutics, Inc.

Micro Therapeutics, Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report