CanadaWhat's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: RF HEAD 24967 PATIENT CONNECTOR; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 24967
Affected products: CareLink SmartSync Device Manager App; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M01A02
Affected products: PROGRAMMER 24970A; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 24970A
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)