Health product recall

Synchro Guidewires

Last updated

Summary

Product
Synchro Guidewires
Issue
Medical devices - Performance issue
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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