Health product recall

Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators

Brand(s)
Last updated

Summary

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

Affected 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Health products - Medical devices - Anaesthesiology
Companies

Abbott Medical

6901 Preston Road, Plano, Texas, United States, 75024

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81998

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