Stryker Recalls Stroke Intervention Kits Due to Label Mismatch
Stryker Neurovascular is recalling specific stroke intervention kits because the carton sleeve labels did not match the physical contents inside the packs.
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, but the source text describes a labeling mismatch without reporting any hospitalizations, injuries, or deaths, aligning with the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Stryker Neurovascular is recalling certain 3-Pack Stroke Fast Packs and Trevo Procedure Packs. The recall was initiated because some of these products were manufactured using a carton sleeve where the label contents did not match the physical contents within the pack.
The affected products include the Trevo(TM) XP ProVue Procedure Pack, which contains the TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, and the Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter. The specific lot number is QX10100894, with an expiration date of 28-Oct-18.
These products were distributed internationally to Germany, Slovakia, and Israel. The source text does not specify the number of units affected or report any illnesses or injuries associated with this labeling discrepancy.
The recalled product
- Product
- Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 1
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 Number QX10100894. Exp. Date 28-Oct-18
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Stryker 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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