The Apollo Onyx Delivery Microcatheter — Class II medical device recall Z-1252-2024
Ongoing recall by Micro Therapeutics, Inc., reported 2024-03-13, distributed nationwide. European version of microcatheter were distributed within US which contain a different "Indications for Use".
| Recall number | Z-1252-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics, Inc., Irvine, CA, United States |
| Recall initiated | 2024-01-11 |
| Classified | 2024-03-04 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 82 units |
| UPC / GTIN / UDI-DI | 00763000311438 |
| Lot numbers | B510757, B593510, B610689 |
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.
Reason for recall
European version of microcatheter were distributed within US which contain a different "Indications for Use".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1252-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.