Trevo Microcatheters and Synchro Devices
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
---|---|---|
Trevo Trak 21 Microcatheter |
136915 |
90338 |
Trevo Pro 14 Microcatheter |
130285 |
90231 |
Synchro Neuro Guidewire |
123364 |
M00313010 |
Issue
Stryker Neurovascular has distributed multiple lots of Trevo Microcatheters and Synchro devices that did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with American National Standard Bacterial Endotoxins-Test methods, routine monitoring, and alternatives to batch testing AAMI ST72 standard. These lots of Stryker Neurovascular devices may exceed the acceptable limits of endotoxin levels.
Recall Start Date: April 29, 2024
Additional information
Details
Stryker Neurovascular
47900 Bayside Parkway, Fremont, California, United States, 94538
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