Ccolade Pacemaker, Mri Pacemaker, Visionist Crt-p And X4 Crt-p (2017-12-19)

Boston Scientific's ACCOLADE pacemakers, MRI pacemakers, VISIONIST CRT-P devices, and X4 CRT-P devices distributed across Canada are being recalled. The devices may malfunction or stop working due to a software issue. This recall affects patients who have received these implanted cardiac devices.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-01-29
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/8963d7ca-ba79-42ec-a576-9591adf887b3