Thermocool Smarttouch Sf Uni-directional And Bi-directional Navigation Catheter (2018-10-20)

Recall Summary ThermoCool SmartTouch SF navigation catheters (both uni-directional and bi-directional models) are being recalled across Canada. The recall was issued on October 20, 2018, and is classified as Class I, indicating a serious safety concern. The specific reason for the recall relates to the medical device itself, though details about the particular defect are not provided in this notice.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-11-28
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/8c887b4e-76ce-45c7-a67f-2a84cbca47eb