Concentric Medical Recalls Trevo Pro 4 Stent Retrievers Due to Labeling Error
Concentric Medical is recalling 10 units of Trevo Pro 4 Stent Retrievers because they were shipped with non-U.S. instructions for use that did not align with U.S. indications.
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 (non-U.S. instructions) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Concentric Medical Inc is recalling 10 units of the Trevo Pro 4 Stent Retriever, Model number 80021. The recall was initiated because the product shipped to U.S. customers contained non-U.S. Instructions for Use. These instructions included indications for use that were not aligned with the approved U.S. indications for the device.
The affected units are distributed in the states of California, Indiana, Pennsylvania, Alabama, and New Jersey. The recall includes units from Lot Numbers 36774, 36432, 36757, and 36761, with expiration dates ranging from December 2014 to March 2015. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Healthcare providers and patients should stop using the affected units and contact Concentric Medical Inc for further instructions. This recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible…
- Manufacturer
- Concentric Medical Inc
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 10
Distribution
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