Health product recall

Infinity 5 and 7 Implantable Pulse Generator

Brand(s)
Last updated

Summary

Product
Infinity 5 and 7 Implantable Pulse Generator
Issue
Medical devices - Labelling and packaging
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Infinity 7 Implantable Pulse Generator

All lots.

6663
6662

Infinity 5 Implantable Pulse Generator

All lots.

6660
6661

Issue

Abbott has initiated a voluntary medical device recall of Implantable Pulse Generator (IPG) for patients with non-rechargeable Infinity™ Deep Brain Stimulation (DBS) 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies

Abbott Medical

6901 Preston Road, Plano, Texas, United States, 75024

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75782

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