Proclaim and Infinity Implantable Pulse Generators
Brand(s)
Last updated
Summary
Product
Proclaim and Infinity Implantable Pulse Generators
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Proclaim Drg Implantable Pulse Generator | All lots. | 3664 |
| Infinity 5 Implantable Pulse Generator | All lots. | 6660 |
| Proclaim Xr 7 Implantable Pulse Generator | All lots. | 3662 |
| Infinity 7 Implantable Pulse Generator | All lots. | 6662 |
| Proclaim Xr 5 Implantable Pulse Generator | All lots. | 3660 |
Issue
Abbott has received complaints from patients who are unable to exit MRI mode, as their patient controller has lost the ability to connect or communicate with their IPG while in MRI mode. Abbott sent a customer communication on 2023-07-21 to remind health care providers about use of the magnetic resonance imaging (MRI) mode feature on these systems and the associated risks related to inability to exit MRI mode, including the potential need for additional surgery to restore therapy.
Recall start date: July 21, 2023
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
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-74120
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