Stryker neurovascular devices recalled for inadequate endotoxin testing
Stryker Neurovascular is recalling Trevo ProVue devices due to manufacturing testing deficiency that may result in unsafe endotoxin levels and risk of fever, shock, or aseptic meningitis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a manufacturing compliance deficiency. While the potential harms—fever, shock, and aseptic meningitis—are serious, no illnesses or hospitalizations are reported and the contamination risk is theoretical based on the 'may exceed' language in the source.
Plain-English summary
Stryker Neurovascular is recalling 280 Trevo ProVue neurovascular devices (Catalog 90184) with Lot Numbers 118117, 118420, and 118833.
During manufacturing, these devices did not meet the minimum sample size required for endotoxin testing and are out of compliance with the AAMI ST72 standard. As a result, the devices may exceed the acceptable limits of endotoxin levels.
High levels of endotoxins may increase the risk of fever, shock, and aseptic meningitis. The FDA has classified this as a Class II recall.
The recalled devices were distributed worldwide and throughout the United States. If you have received these devices, contact your healthcare provider or Stryker Neurovascular for guidance.
The recalled product
- Product
- Trevo ProVue, Catalog: 90184
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- endotoxin
- fever
- shock
- aseptic-meningitis
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 (5)
- Catalog: 90184
- UDI-DI: 00815742001846
- Lot: 118117
- 118420
- 118833
Distribution
Distributed nationwide across the United States.
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