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.
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: 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
- endotoxin
- bacterial-toxin
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
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27