Z-1253-2024Class II

The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed...

Name: Z-1253-2024 The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed...
Creator: Micro Therapeutics, Inc.
Published: 2024-01-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-01-11 / Open, Classified

FDA source

Micro Therapeutics, Inc. began a recall of 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... on 2024-01-11. FDA classified it as Class II and gives the reason as "European version of microcatheter were distributed within US which contain a different "Indications for Use"". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1253-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-11
Posted: 2024-03-04
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: MFE Agent, Injectable, Embolic
Reason for recall: European version of microcatheter were distributed within US which contain a different "Indications for Use".
FDA root cause: Under Investigation by firm
Action: On January 11, 2024, Medtronic Neurovascular issued a "Urgent: Medical Device Recall" Medtronic ask consignees to take the following action: 1. Do not use any impacted product. Remove and quarantine all unused impacted product in your inventory. 2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If an alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3. Complete and return the Customer Confirmation form enclosed with this letter acknowledging that you have received this information.
Quantity in commerce: 95 units
Distribution: 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.
Product codes and lots: UDI: 00763000311445/ Lot # B510758, B555761, B615024, B615025, B629693, B629694

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1253-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1252-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-04
Z-1253-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-04

Product code MFE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)