Health product recall

Guider Softip

Last updated

Summary

Product
Guider Softip
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 catalogue number

Guider Softip Xf

More than 10 numbers, contact manufacturer.

H965100440
M003101430
M003101620
M003101440
H965100430
M003101420

Guider Softip

More than 10 numbers, contact manufacturer.

M003101620
M003100620

Issue

Stryker Neurovascular has observed that certain lots of guider Softip™ Xf guide catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Recall start date: August 2, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74138

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