Proclaim Implantable Pulse Generators
Brand(s)
Last updated
Summary
Product
Proclaim Implantable Pulse Generators
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 |
|---|---|---|
| Proclaim XR 7 Implantable Pulse Generator | All lots. | 3662 |
| Proclaim 5 Implantable Pulse Generator | All lots. | 3665 3661 |
| Proclaim DRG Implantable Pulse Generator | All lots. | 3664 |
| Proclaim XR 5 Implantable Pulse Generator | All lots. | 3660 |
| Proclaim 7 Implantable Pulse Generator | All lots. | 3667 3663 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
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-75786
Get notified
Receive notifications for new and updated recalls and alerts by category.