Public recall detail

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

2026-04-30

medium
Neurology - Anaesthesiology Device compatibility - Performance
Quick summary

Quick summary: Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators . Reason: Device compatibility - Performance. Category: Neurology - Anaesthesiology. Date: 2026-04-30.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Abbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators . Reason: Device compatibility - Performance. Category: Neurology - Anaesthesiology. Date: 2026-04-30.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandABBOTT MEDICAL
ProductAbbott's Proclaim™ SCS/Proclaim™ DRG/Infinity™ DBS Implantable Pulse Generators
IssueMedical devices - Device compatibility Medical devices - Performance
Recall classType II
IdentificationRA-81998

Affected products

ProductInfinity™ 5 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model6660
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionInfinity™ 5 Implantable Pulse Generator
ProductInfinity™ 5 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model6661
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionInfinity™ 5 Implantable Pulse Generator
ProductProclaim™ XR 5 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model3660
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionProclaim™ XR 5 Implantable Pulse Generator
ProductProclaim™ XR 7 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model3662
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionProclaim™ XR 7 Implantable Pulse Generator
ProductProclaim™ 5 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model3665
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionProclaim™ 5 Implantable Pulse Generator
ProductProclaim™ 5 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model3661
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionProclaim™ 5 Implantable Pulse Generator
ProductProclaim™ 7 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model3667
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionProclaim™ 7 Implantable Pulse Generator
ProductProclaim™ 7 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model3663
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionProclaim™ 7 Implantable Pulse Generator
ProductProclaim™ DRG Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model3664
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionProclaim™ DRG Implantable Pulse Generator
ProductInfinity™ 7 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model6663
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionInfinity™ 7 Implantable Pulse Generator
ProductInfinity™ 7 Implantable Pulse Generator
LotMore than 100 numbers, contact manufacturer.
Model6662
Serial numberMore than 100 numbers, contact manufacturer.
DescriptionInfinity™ 7 Implantable Pulse Generator

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology Health products - Medical devices - Anaesthesiology
CompaniesAbbott Medical 6901 Preston Road, Plano, Texas, United States, 75024
Recall date2026-04-17
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81998
Background{}
CompaniesAbbott Medical 6901 Preston Road, Plano, Texas, United States, 75024
AudiencesHealthcare
Source updated2026-04-30

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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