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Health Canada Medical devices

Proclaim Implantable Pulse Generators

Issued July 4, 2024
Issue
Abbott has initiated a voluntary medical device recall of Implantable Pulse Generator (IPG) for patients with non-rechargeable proclaim neurostimulation systems as the duration between the IPG reaching battery elective replacement indicator (ERI) threshold and end of service (EOS) may be 45-55% shorter than indicated in the product labeling. Recall Start Date: June 6, 2024
Hazard description
Labelling and packaging - Performance
Product
Product name
Proclaim Implantable Pulse Generators
Reference
ID
RA-75786