Public recall detail

TCN™ and CSK Reusable RF electrodes

2026-05-07

medium
Neurology Performance
Quick summary

Quick summary: TCN™ and CSK Reusable RF electrodes. Reason: Performance. Category: Neurology. Date: 2026-05-07.

Recommended action

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

Recall details

Quick summary: TCN™ and CSK Reusable RF electrodes. Reason: Performance. Category: Neurology. Date: 2026-05-07.

Official details

Affected product details

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

BrandBoston Scientific Neuromodulation Corporation
ProductTCN™ and CSK Reusable RF electrodes
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82046

Affected products

ProductTCN™, Nitinol
LotAll lots.
ModelTCN-15-3M
Serial numberAll lots.
DescriptionTCN™, Nitinol
ProductTCN™, Nitinol
LotAll lots.
ModelTCN-10-3M
Serial numberAll lots.
DescriptionTCN™, Nitinol
ProductTCN™, Nitinol
LotAll lots.
ModelTCN-5-3M
Serial numberAll lots.
DescriptionTCN™, Nitinol
ProductTCN™, Nitinol
LotAll lots.
ModelTCN-20-3M
Serial numberAll lots.
DescriptionTCN™, Nitinol
ProductTCN™ Electrode
LotAll lots.
ModelTCN-20
Serial numberAll lots.
DescriptionTCN™ Electrode
ProductTCN™ Electrode
LotAll lots.
ModelTCN-15
Serial numberAll lots.
DescriptionTCN™ Electrode
ProductTCN™ Electrode
LotAll lots.
ModelTCN-5
Serial numberAll lots.
DescriptionTCN™ Electrode
ProductTCN™ Electrode
LotAll lots.
ModelTCN-10
Serial numberAll lots.
DescriptionTCN™ Electrode
ProductCSK Electrode
LotAll lots.
ModelCSK-TC10
Serial numberAll lots.
DescriptionCSK Electrode
ProductCSK Electrode
LotAll lots.
ModelCSK-TC15-3M
Serial numberAll lots.
DescriptionCSK Electrode
ProductCSK Electrode
LotAll lots.
ModelCSK-TC20
Serial numberAll lots.
DescriptionCSK Electrode
ProductCSK Electrode
LotAll lots.
ModelCSK-TC5-3M
Serial numberAll lots.
DescriptionCSK Electrode
ProductCSK Electrode
LotAll lots.
ModelCSK-TC5
Serial numberAll lots.
DescriptionCSK Electrode
ProductCSK Electrode
LotAll lots.
ModelCSK-TC10-3M
Serial numberAll lots.
DescriptionCSK Electrode
ProductCSK Electrode
LotAll lots.
ModelCSK-TC15
Serial numberAll lots.
DescriptionCSK Electrode

Issue

Boston Scientific has determined that the TCN™, and CSK reusable RF electrodes may not consistently meet the expected performance levels throughout the specified 20 sterilization cycles for re-use. This determination was based on recent review of internal laboratory testing.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesBoston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop, Valencia, California, United States, 91355
Recall date2026-04-29
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82046
Background{}
CompaniesBoston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop, Valencia, California, United States, 91355
AudiencesHealthcare
Source updated2026-05-07

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

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