Ev3 Neurovascular Recalls Mislabeled Marathon Flow Directed Micro Catheters
Ev3 Neurovascular is recalling 23 units of Marathon Flow Directed Micro Catheters because one lot may have been mislabeled.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as mislabeling without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 23 units of Marathon Flow Directed Micro Catheters, Model #105-5055. The recall was initiated because the company identified that one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
The affected product is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents, such as embolization materials, and diagnostic materials, such as contrast media. The specific lot number is 9374210.
The product was distributed worldwide, including nationwide in the United States (specifically Minnesota, Florida, Oregon, and Texas) and in Brazil, Belgium, the Czech Republic, Finland, France, Germany, the Netherlands, Poland, and the United Kingdom. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization mate
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 23
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 (1)
- Lot # 9374210
Distribution
Part of a larger recall action
This product is one of 2 recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular 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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