Public recall detail

CareLink™ SmartSync™ Device Manager

2026-10-01

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Health products Health product recall
Quick summary

Quick summary: CareLink™ SmartSync™ Device Manager. Reason: Health product recall. Category: Health products. Date: 2026-10-01.

Recommended action

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

Recall details

Quick summary: CareLink™ SmartSync™ Device Manager. Reason: Health product recall. Category: Health products. Date: 2026-10-01.

Official details

Affected product details

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

BrandMEDTRONIC INC.
ProductCareLink™ SmartSync™ Device Manager
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82715

Affected products

ProductRF HEAD 24967 PATIENT CONNECTOR
LotMore than 10 numbers, contact manufacturer.
Model24967
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionRF HEAD 24967 PATIENT CONNECTOR
ProductCareLink SmartSync Device Manager App
LotMore than 10 numbers, contact manufacturer.
ModelM01A02
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCareLink SmartSync Device Manager App
ProductPROGRAMMER 24970A
LotMore than 10 numbers, contact manufacturer.
Model24970A
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPROGRAMMER 24970A

Issue

A complaint from the CareLink network reported a sudden decrease in the Remaining Longevity of a patient's Micra VR CIED from 3 years to 6 months following a remote transmission, which was later found to be incorrect. Analysis revealed a calculation issue in SmartSync and CareLink for Micra VR2 and Micra AV2 devices, occurring under specific conditions. This miscalculation stems from a software error where a function received an integer instead of a real data type, defaulting the average pacing rate to 60 BPM and resulting in inaccurate Remaining Longevity estimates.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use Health products - Medical devices - Cardiovascular
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Recall date2026-09-24
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82715
Background{}
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
AudiencesHealthcare
Source updated2026-10-01

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

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