CFIA - Canadian Food Inspection Agency

04/30/2026 | Press release | Distributed by Public on 04/30/2026 09:51

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

Health product recall

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

Brand(s)
Last updated
2026-04-30

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: 2026-04-30
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
2026-04-17
Identification number
RA-81998

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CFIA - Canadian Food Inspection Agency published this content on April 30, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 30, 2026 at 15:51 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]