Visionist Crt-p, X4 Crt-p And Autogen Crt-d (2017-12-19)

Recall Summary Abbott is recalling VISIONIST CRT-P, X4 CRT-P, and Autogen CRT-D cardiac devices due to a potential software issue that could cause the device to stop delivering therapy. The recall affects devices distributed across Canada. Patients using these cardiac resynchronization therapy devices should contact their healthcare provider.

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/8f9ed117-8e6a-46eb-8ce0-8bbcb025d23b