Back to RecallTracker
Health Canada Medical devices

Trevo Microcatheters and Synchro Devices

Issued August 14, 2024
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
Hazard description
Sterility
Product
Product name
Trevo Microcatheters and Synchro Devices
Reference
ID
RA-75919