Recall MonitorHealth Products
Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Neurology, Health products - Medical devices - Anaesthesiology
Product: Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators
Issue: Medical devices - Device compatibility, Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Infinity™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6660 |
| Infinity™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6661 |
| Proclaim™ XR 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3660 |
| Proclaim™ XR 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3662 |
| Proclaim™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3665 |
| Proclaim™ 5 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3661 |
| Proclaim™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3667 |
| Proclaim™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3663 |
| Proclaim™ DRG Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 3664 |
| Infinity™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6663 |
| Infinity™ 7 Implantable Pulse Generator | More than 100 numbers, contact manufacturer. | 6662 |
Issue
Abbott is sharing important information regarding the Infinity™ Deep Brain Stimulation (DBS) Neurostimulation System, Proclaim™ Spinal Cord Stimulation (SCS) and Proclaim™ Dorsal Root Ganglion (DRG) Neurostimulation Systems. The purpose of this communication is to remind health care providers that the systems contain a Surgery Mode feature designed to help protect the implanted device from potential interference associated with the use of electrosurgical units (ESUs) during certain surgical procedures.