Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch
Stryker Neurovascular is recalling specific Stroke Fast Packs and Trevo Procedure Packs 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, and the hazard is a labeling mismatch rather than a direct physical defect or contamination, fitting the criteria for moderate severity.
Plain-English summary
Stryker Neurovascular is recalling specific 3-Pack Stroke Fast Packs and Trevo Procedure Packs. The recall is due to a manufacturing issue where the carton sleeve label contents did not match the physical contents within the pack.
The affected products include the Stroke Fast Pack, Trevo XP, Trevo Pro 18, and AXS Catalyst 6 distal access catheter. The recall involves 2 units with specific lot numbers and expiration dates. These products were distributed internationally to Germany, Slovakia, and Israel.
Healthcare providers and facilities that have received these products should stop using them and contact Stryker Neurovascular for further instructions. This recall addresses a labeling discrepancy to ensure the correct medical devices are used during procedures.
The recalled product
- Product
- Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 2
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 (4)
- Lot Number QPC30200039
- Exp. Date 28-Aug-18
- QPC30200114
- Exp. Date 28-Mar18
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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