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
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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