Mammotome Revolve Dual Vacuum Assisted Biopsy System (2016-05-26)

Recall Summary Hologic Inc. is recalling the Mammotome Revolve Dual Vacuum Assisted Biopsy System across Canada due to a potential malfunction where the biopsy needle may not fully retract into its protective sheath during use. This device is used to perform breast biopsies in medical settings. The recall affects all units of this system that were distributed in Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2016-06-24
Status
Closed
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2fe0e4fc-82aa-4449-891d-83d452f3a718