Health product recall

Synchro Guidewires

Last updated

Summary

Product
Synchro Guidewires
Issue
Medical devices - Performance
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
Synchro 2/ Soft Guidewire More than 10 numbers, contact manufacturer. M00326010 M00326310
Synchro 2/ Standard Guidewire More than 10 numbers, contact manufacturer. M00326410 M00326510
Synchro 2/ Soft Preshaped Guidewire 0000069276 0000082965 0000126054 M00326110
Synchro 2/ Standard Preshaped Guidewire 0000161018 0000152226 0000084099 0000174675 0000070864 M00326420
Synchro Neuro Guidewires With Hydrophilic Coating More than 10 numbers, contact manufacturer. M00313310 M00313010 M00316310 M00316330
Synchro Select Standard Guidewire With Hydrophilic Coating More than 10 numbers, contact manufacturer. SSTD215PRE SSTD300STR SSTD215STR
Synchro Select Soft Guidewire With Hydrophilic Coating 0000126356 0000123405 0000129220 0000124931 0000133179 0000125787 0000144375 0000131723 0000123151 SSFT300STR SSFT215STR
Synchro Select Support Guidewire With Hydrophilic Coating More than 10 numbers, contact manufacturer. SSUP215STR SSUP300PRE SSUP300STR
Synchro2 Guidewire, Support More than 10 numbers, contact manufacturer. S2SPP14215 S2SPS14215 S2SPS14300

Issue

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory.

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-75522

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