Lower riskMedical device recall · FDA · Published January 11, 2024
Micro Therapeutics Apollo Onyx Microcatheter Recall: Different US Indications for Use
Micro Therapeutics recalls Apollo Onyx Delivery Microcatheter (AOMC) sold in US with different indications for use than European version. This may lead to improper medical use. Contact for details.
“Micro Therapeutics Apollo Onyx Microcatheter Recall: Different US Indications for Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56331-micro-therapeutics-apollo-onyx-microcatheter-recall-different-us-indications-for. Based on FDA recall #Z-1253-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2024%22&limit=1).
The FDA announced on Jan. 11, 2024, that Micro Therapeutics, Inc. is recalling the Apollo Onyx Delivery Microcatheter because European versions distributed in the U.S. contain different indications for use. The recall affects 95 units nationwide.
How to tell if you have it
Brand: Micro Therapeutics
Product: The Apollo Onyx Delivery Microcatheter (AOMC)
UDI: 00763000311445
Lot codes: B510758, B555761, B615024, B615025, B629693, B629694
The hazard
The European version of the microcatheter was distributed within the U.S. and contains a different "Indications for Use" than intended for the U.S. market.
Context
GovInfoNow's records show Micro Therapeutics, Inc. has had six other recalls on record since July 13, 2021. Other recent recalls of similar products include Medline Medical Procedure Kits Recall: Catheter Issues (May 4, 2026) and Microvention Bobby Balloon Guide Catheter Recall: Balloon Pinhole Defects (April 30, 2026).
How to tell if you have this one
Check for the UDI code 00763000311445 and lot numbers B510758, B555761, B615024, B615025, B629693, B629694 on the catheter packaging or label.
Brand
Micro Therapeutics
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Recall number
Product, codes & lots
Quantity
Z-1252-2024
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.; UDI: 00763000311438/ Lot # B510757, B593510, B610689
82 units
Z-1253-2024
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.; UDI: 00763000311445/ Lot # B510758, B555761, B615024, B615025, B629693, B629694
95 units
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the UDI code 00763000311445 and lot numbers B510758, B555761, B615024, B615025, B629693, B629694 on the catheter packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 30 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall is due to a difference in intended medical uses between the US and European versions, not a direct risk of serious injury. The danger level is low risk.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1253-2024 (January 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1253-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.