Trevo Pro Microcatheters Recalled for Potential Endotoxin Contamination
Stryker Neurovascular is recalling Trevo Pro 14 and 18 Microchethers worldwide due to non-compliance with endotoxin testing standards. High endotoxin levels could cause fever, shock, and meningitis.
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 3/5 (High).
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 medical devices used in critical procedures where endotoxin contamination could cause serious complications (fever, shock, meningitis). However, no illnesses or injuries have been reported in the source text, and the hazard is theoretical—devices may exceed acceptable limits but contamination is not confirmed. Per the rubric, this fits Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Neurovascular is recalling 648 Trevo Pro 14 Microcatheter (Catalog 90231) and Trevo Pro 18 Microcatheter (Catalog 90238) units worldwide. These devices did not meet the minimum sample size required for endotoxin testing during manufacturing and are out of compliance with the AAMI ST72 standard. As a result, they may exceed acceptable endotoxin levels.
High endotoxin levels could increase the risk of fever, shock, and aseptic meningitis during medical use. Stryker Neurovascular initiated this recall due to the manufacturing compliance issue and potential hazard.
The affected devices have been distributed globally to healthcare facilities in all U.S. states and territories, as well as numerous countries including Australia, Canada, and throughout Europe and Asia.
The recalled product
- Product
- Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 648
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 (10)
- Catalog/UDI-DI/Lot: 90231/00815742002317/121050
- 129849
- 129882
- 130285
- 136439
- 136628
- 143375
- 143476
- 90238/00815742002386/136009
- 198334
Distribution
Part of a larger recall action
This product is one of 8 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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