Stryker Recalls Trevo XP ProVue System Due to Carton Mismatch
Stryker Neurovascular is recalling one Trevo XP ProVue System kit because the carton sleeve did not match the physical contents of the pack.
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. The hazard is a labeling/packaging mismatch (carton sleeve did not match contents) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall or minor labeling error.
Plain-English summary
Stryker Neurovascular is recalling one Trevo XP ProVue System kit. The product consists of a Trevo XP ProVue Retriever (4x20mm) and a Trevo Pro18 Microcatheter. The recall is due to a manufacturing error where the carton sleeve did not match the physical contents of the pack.
The affected unit is identified by UPN/Model No. 80052 and Lot 63034. The distribution pattern for this specific recall is listed as OUS only, specifically in the Netherlands, France, Italy, Germany, and Belgium.
Healthcare providers and facilities should check their inventory for this specific lot and model number. If the product is found, it should be removed from use and returned to Stryker Neurovascular according to their instructions. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
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 (2)
- UPN/Model No. 80052
- Lot 63034
Distribution
Distribution scope not specified by the agency.
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