Trevo Microcatheters and Synchro Devices
Brand(s)
Last updated
Summary
Product
Trevo Microcatheters and Synchro Devices
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Trevo Trak 21 Microcatheter | 136915 140598 136914 119461 140512 136913 | 90338 |
| Trevo Pro 14 Microcatheter | 130285 129882 | 90231 |
| Synchro Neuro Guidewire | 123364 123851 | M00313010 M00316310 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - Neurology
Companies
Stryker Neurovascular
47900 Bayside Parkway, Fremont, California, United States, 94538
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75919
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