FDA Recalls Apollo Onyx Delivery Microcatheter Due to Labeling Mismatch
FDA is recalling Apollo Onyx Delivery Microcatheters distributed in the US with incorrect European labeling. The devices contain different indications for use than those approved for the US market.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance—European-approved indications distributed on devices intended for US use—creating a risk of improper clinical application.
Plain-English summary
Micro Therapeutics, Inc. is recalling the Apollo Onyx Delivery Microcatheter (AOMC) following discovery that European-labeled versions were distributed in the United States. The recalled devices contain indications for use that differ from FDA-approved US labeling.
The AOMC is a medical device designed to deliver the Onyx liquid embolic system during interventional procedures. The distribution included 82 units across lot numbers B510757, B593510, and B610689, reaching healthcare facilities in 29 states nationwide.
Healthcare providers who received these devices should immediately verify they have the correct US-approved labeling and indications for use. Patients who may have been treated using this device should consult their healthcare provider if they have concerns.
The recalled product
- 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…
- Manufacturer
- Micro Therapeutics, Inc.
- Hazard
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI: 00763000311438/ Lot # B510757
- B593510
- B610689
Distribution
Part of a larger recall action
This product is one of 2 recalled by Micro Therapeutics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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