Health product recall

Trevo Microcatheters and Synchro Devices

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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