Boston Scientific recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…
Boston Scientific Corporation is recalling LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS… – N/A. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 6, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS… |
| Brand | Boston Scientific |
| Company | Boston Scientific Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 6, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | N/A |
| Recall ID | 99524 |
Recalled products (3)
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
- FDA recall number
- Z-3081-2026
- Codes, lots and dates
- UDI-DI: 00802526613838
- Quantity
- N/A
- Classification
- Class II
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
- FDA recall number
- Z-3082-2026
- Codes, lots and dates
- UDI-DI: 00802526613883
- Quantity
- N/A
- Classification
- Class II
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
- FDA recall number
- Z-3083-2026
- Codes, lots and dates
- UDI-DI: 00802526613852
- Quantity
- N/A
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99524
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Saint Paul, MN, United States
Why it was recalled
The reason the FDA lists: “There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide - US Nationwide distribution.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99524, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Boston Scientific recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  Boston Scientific recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5Medical devices · 262,686 | Tip may fracture or detach, leading to device fragments remaining within the patient or mi… Most serious | FDA Class I |
| Sep 23, 2026 | Boston Scientific recall: Corporation StoneSmart Connect Console Contents:Medical devices · 982 units | A subset of power adapters used with the connect console may exhibit higher-than-expected … Serious | FDA Class II |
| Aug 26, 2026 | Boston Scientific recall: ENROUTE Transcarotid Neuroprotection System and 1 more productMedical devices · 115,458 units; 49,229 units | Potential for arterial sheath tip separation or partial tip separation during use. Most serious | FDA Class I |
| Aug 26, 2026 | Boston Scientific recall: OverStitch Suture Cinch and 1 more productMedical devices · 60,654 units | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Serious | FDA Class II |
All 5 Boston Scientific recalls →
About this recall
Is Boston Scientific LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS… recalled?
Yes. Boston Scientific Corporation recalled it on August 6, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.