Stryker Neurovascular Trevo Pro Microcatheter Recalled for Unevaluated Use Statement
Stryker is recalling the Trevo Pro 18 Microcatheter because its instruction manual contains an intended use that the FDA has not evaluated. The recall affects 11 units distributed across the United States.
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: This is an FDA Class II recall for a labeling and regulatory compliance issue—the IFU contains an intended use statement not evaluated by the FDA. With no reported illnesses, injuries, or device malfunctions, this fits the Moderate (Score 2) category: labeling errors and precautionary recalls without reported harm.
Plain-English summary
Stryker, Inc. is recalling the Trevo Pro 18 Microcatheter (model reference 90238, 0.021 inch diameter, 150 centimeter length) due to a regulatory compliance issue. The instruction for use (IFU) provided with the device contains an intended use statement that has not been evaluated by the FDA.
The recall affects 11 units with lot numbers 0000228865 and 0000370674. These devices were distributed nationwide to locations in Alabama, Florida, Georgia, Hawaii, Illinois, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Texas, and Virginia.
Healthcare facilities and providers who have received this device should stop using the affected units and contact Stryker, Inc. for instructions on returns or replacements. Patients or providers with questions should consult with Stryker's medical team.
The recalled product
- Product
- Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
- Manufacturer
- Stryker, Inc.
- Category
- Medical Device — Neurovascular
- Hazard
- unevaluated-use
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)
- UDI: (01)00815742002386/Lot Number(s): 0000228865 0000370674
Distribution
Distributed nationwide across the United States.
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