Micro Therapeutics, Inc. is recalling 177 units of its Apollo Onyx Delivery Microcatheter (AOMC) because the European versions of the device were mistakenly distributed within the United States. These units contain 'Indications for Use' documentation that differs from the FDA-cleared version, which may lead to improper medical use. This recall affects two specific product codes distributed across 30 states between January and March 2024. Consumers should contact their healthcare provider or the manufacturer for further instructions.
The use of a medical device with incorrect instructions for use could result in the device being used for procedures or in ways it was not intended for. This could potentially lead to procedural complications or patient injury during neurovascular surgeries.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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