Health product recall

CareLink™ SmartSync™ Device Manager

Brand(s)
Last updated

Summary

Product
CareLink™ SmartSync™ Device Manager
Issue
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

RF HEAD 24967 PATIENT CONNECTOR

More than 10 numbers, contact manufacturer.

24967

CareLink SmartSync Device Manager App

More than 10 numbers, contact manufacturer.

M01A02

PROGRAMMER 24970A

More than 10 numbers, contact manufacturer.

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. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Cardiovascular
Companies

Medtronic Inc.

710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82715

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