Proclaim Implantable Pulse Generators

Proclaim Implantable Pulse Generators Recall Summary Proclaim Implantable Pulse Generators are being recalled across Canada due to labelling and packaging issues that affect product performance. This Class I recall affects patients who have received or may receive these devices. The devices are used for pain management through electrical stimulation therapy.

Product
Proclaim Implantable Pulse Generators
Reason
Labelling and packaging - Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-07-04
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9957b01d-55bd-4375-b8b6-1b78851b5429