OFFICIAL-SOURCE RECALL · CANADA
CareLink™ SmartSync™ Device Manager Recall: A complaint from the CareLink network reported a
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Is your product affected?
- Brand
- See official notice
- Product
- CareLink™ SmartSync™ Device Manager
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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.
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.
Official recall notice
CareLink™ SmartSync™ Device Manager
Agency: Health Canada
Official publication date: October 1, 2026
Read the official CANADA_HEALTH recall notice →SCAN ONCE. KEEP WATCHING.
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