Proclaim Implantable Pulse Generators
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
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 |
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
Abbott Medical
6901 Preston Road, Plano, Texas, United States, 75024
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