Recall Z-1252-2024
Micro Therapeutics, Inc. · initiated January 11, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: UDI: 00763000311438/ Lot # B510757, B593510, B610689
Reason for recall
European version of microcatheter were distributed within US which contain a different "Indications for Use".
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1252-2024
- Initiated
- January 11, 2024
- Posted by FDA
- March 4, 2024
- Product code
- MFE – Agent, Injectable, Embolic
- Quantity
- 82 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.
- Recalling firm
- Micro Therapeutics, Inc., Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1253-2024 Class II | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end…European version of microcatheter were distributed within US which contain a different "Indications for Use". | 01/11/2024Open, Classified |