Trevo NXT neurovascular devices recalled for inadequate endotoxin testing
Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause 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: This is an FDA Class II recall involving a serious potential hazard—endotoxin contamination may cause fever, shock, and aseptic meningitis. However, no illnesses or injuries are reported in the source text. Per the severity rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).
Plain-English summary
Stryker Neurovascular is recalling Trevo NXT ProVue neurovascular intervention devices and related catheter kits. The recall affects 204 units distributed worldwide and across the United States.
The devices did not meet the minimum sample size required for endotoxin testing during manufacturing, putting them out of compliance with the AAMI ST72 standard. As a result, these devices may contain endotoxin levels that exceed acceptable limits.
Endotoxins are bacterial toxins that can trigger serious systemic inflammatory responses. High endotoxin levels may increase the risk of fever, shock, and aseptic meningitis in patients receiving these interventions.
Healthcare facilities using or possessing affected products should contact Stryker Neurovascular for guidance on product handling and return procedures.
The recalled product
- Product
- Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2
- Manufacturer
- Stryker 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 (20)
- Catalog/UDI-DI/Lot: 90312/07613327299922/118881
- 91412/07613327500684/48483279
- 48483281
- 48483294
- 48696618
- 48696619
- 48696620
- 48715713
- 48834692
- 48834695
- 48834696
- 91413/07613327500691/48483280
- 48483284
- 48483289
- 48483291
- 48483316
- 48483317
- 48696613
- 48696622
- 48696623
Distribution
Distributed nationwide across the United States.
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