Recall Z-1253-2024 ยท MFE Agent, Injectable, Embolic
Micro Therapeutics, Inc.
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 att
| Date | Mar 4, 2024 (initiated Jan 11, 2024) |
| Status | Open, Classified |
| Reason | European version of microcatheter were distributed within US which contain a different "Indications for Use". |
| 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 lette |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.