Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch
Stryker Neurovascular is recalling 63 Stroke Fast Packs because the printed carton contents did not match the physical items inside.
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/packaging mismatch without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Stryker Neurovascular is recalling 63 Stroke Fast Packs (Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM) distributed nationwide. The recall was initiated because the pre-printed contents on the back of the carton sleeve did not match the physical contents of the pack.
The affected products are identified by the following lot numbers: QPC30107530, QPC30107745, QPC30107814, and QPC30110247. The agency has classified this as a Class II recall.
Healthcare providers and facilities should stop using the affected packs and contact Stryker Neurovascular for instructions on return or replacement. This recall addresses a packaging and labeling discrepancy rather than a defect in the medical devices themselves.
The recalled product
- Product
- Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 63
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 Numbers: QPC30107530
- QPC30107745
- QPC30107814
- QPC30110247
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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