Gore Excluder System (2019-12-18)

GORE EXCLUDER System Recall Summary The GORE EXCLUDER System, a medical device, has been recalled across Canada due to a manufacturing issue. This recall affects units of this device that were distributed throughout Canada. The device manufacturer has classified this as a Class I recall, which is the most serious classification for medical devices.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2020-01-24
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9ede76e8-58ac-45cd-b142-88e59ec397b2