Recall MonitorHealth Products
CareLink™ SmartSync™ Device Manager
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use, Health products - Medical devices - Cardiovascular
Product: CareLink™ SmartSync™ Device Manager
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.