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U.S. Department of Health and Human Services

Class 2 Device Recall Apollo Onyx Delivery Micro Catheter

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  Class 2 Device Recall Apollo Onyx Delivery Micro Catheter see related information
Date Initiated by Firm January 11, 2024
Date Posted March 04, 2024
Recall Status1 Open3, Classified
Recall Number Z-1253-2024
Recall Event ID 93922
Product Classification Agent, injectable, embolic - Product Code MFE
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.
Code Information UDI: 00763000311445/ Lot # B510758, B555761, B615024, B615025, B629693, B629694
Recalling Firm/
Manufacturer		 Micro Therapeutics, Inc.
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact Kelli Lynch
508-261-8000
Manufacturer Reason
for Recall		 European version of microcatheter were distributed within US which contain a different "Indications for Use".
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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