OFFICIAL-SOURCE RECALL · AUSTRALIA
LATITUDE Clarity Server Software Recall: Classification Class II Reason for the Action There
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Is your product affected?
- Brand
- See official notice
- Product
- LATITUDE Clarity Server Software
- Manufacturer
- See official notice
- GTIN
- 00802526613852
- Lot number
- numbers
- Batch number
- numbers
- Model number
- 7248
- Date code
- dates
- Expiration date
- dates
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
Classification Class II Reason for the Action There is a potential for a delay in AF Burden Alert notification affecting the LATITUDE Clarity server software which supports the LUX-Dx family of ICMs. This delayed AF Burden Alert notification behaviour by LATITUDE Clarity may occur if the Alert for AF Burden = Threshold is configured to ">0 hours per day" setting (a non-default configuration). Boston Scientific has received one complaint globally related to this delayed notification behaviour with no patient injuries or deaths reported. Instructions for Customers/Users A server software update is planned to correct this behavior. Until updated server software is available, customers should consider the following options: 1. Change Threshold for AF Burden Alert Setting 2. Enable AF Events Alert with Minimum Duration 3. If Unchanged, Potential Delay in AF Burden Alert Notification The customer letter has instructions for each of these options. NB: Boston Scientific does not recommend replacement of the implanted ICM. Action Commencement Date 3/08/2026 Responsible Entity Boston Scientific Pty Ltd
Hazard
Classification Class II Reason for the Action There is a potential for a delay in AF Burden Alert notification affecting the LATITUDE Clarity server software which supports the LUX-Dx family of ICMs. This delayed AF Burden Alert notification behaviour by LATITUDE Clarity may occur if the Alert for AF Burden = Threshold is configured to ">0 hours per day" setting (a non-default configuration). Boston Scientific has received one complaint globally related to this delayed notification behaviour with no patient injuries or deaths reported. Instructions for Customers/Users A server software update is planned to correct this behavior. Until updated server software is available, customers should consider the following options: 1. Change Threshold for AF Burden Alert Setting 2. Enable AF Events Alert with Minimum Duration 3. If Unchanged, Potential Delay in AF Burden Alert Notification The customer letter has instructions for each of these options. NB: Boston Scientific does not recommend replacement of the implanted ICM. Action Commencement Date 3/08/2026 Responsible Entity Boston Scientific Pty Ltd
Official recall notice
LATITUDE Clarity Server Software
Agency: Therapeutic Goods Administration
Official publication date: August 3, 2026
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