Ev3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters
Ev3 Neurovascular is recalling 36 UltraFlow HPC Flow Directed Micro Catheters because one lot may have been mislabeled.
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 2/5 (Moderate).
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 and involves a labeling error without reported injuries or illnesses, which aligns with the rubric for moderate severity.
Plain-English summary
Ev3 Neurovascular is recalling 36 units of the UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. 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 peripheral and neuro vasculature for the controlled selective infusion of therapeutic and diagnostic materials. The recall covers Lot # 9374298.
The product was distributed worldwide, including in the United States (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 further instructions for consumers or healthcare providers.
The recalled product
- Product
- UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as…
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 36
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 # 9374298
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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