Stryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing
Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic 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: Endotoxin is a high-risk bacterial toxin capable of causing serious systemic conditions (fever, shock, aseptic meningitis), meeting the Score 3 criterion for risk-of-harm products. No illnesses or injuries are reported in the source material.
Plain-English summary
The Trevo Trak 21 Microcatheter (Catalog 90338), manufactured by Stryker Neurovascular, is being recalled worldwide. The recall involves 899 units distributed across the United States and multiple countries internationally.
The 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, the devices may exceed acceptable limits of endotoxins.
Endotoxins are bacterial toxins that can trigger serious systemic reactions. High levels of endotoxins may increase the risk of fever, shock, and aseptic meningitis. The affected lot numbers are 119461, 119473, 119598, 120070, 120201, 120970, 140512, 136912, 136913, 136914, and 136915.
The recalled product
- Product
- Trevo Trak 21 Microcatheter, Catalog: 90338
- Manufacturer
- Stryker Neurovascular
- Hazard
- Affected units
- 899
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 (13)
- Catalog: 90338
- UDI-DI: 07613327313956
- Lot: 119461
- 119473
- 119598
- 120070
- 120201
- 120970
- 140512
- 136912
- 136913
- 136914
- 136915
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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