LUX-Dx II+ recallZ-2049-2026 · Boston Scientific Corporation · initiated Mar 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
FDA root cause category: Under Investigation by firm
What the company is doing
An IMPORTANT Medical Device Correction notification letter dated 3/30/26 was sent to customers. Recommendations As noted previously, Boston Scientific released an update to LATITUDE Clarity on March 27, 2026 to correct this programming discrepancy. Devices impacted by this issue will be automatically corrected to the clinician assigned programming once the device successfully reconnects with LATITUDE Clarity. To confirm updated programming settings have been applied to the impacted M302/M312 device: " Navigate to the patient s profile on LATITUDE Clarity; " Verify that the last connection to the device occurred after March 27, 2026. If not, the patient will need to reconnect their mobile monitor; " Check device programming under Counters and Settings and verify that Brady, Pause, and PVC Burden are set as desired; " Complete and return the enclosed Acknowledgment Form per the instructions. Boston Scientific s RhythmCARE" Support Team is available to assist HCPs with resolving this programming discrepancy, confirming programmed settings, or assisting with reconnecting a patient, either remotely or in-clinic. Additional Information Patient safety remains Boston Scientific s highest priority. We recognize the impact of this device behavior on both you and your patients, and we are committed to transparent communication with physicians and other HCPs to ensure you have relevant information for managing your patients. If you have additional questions regarding the information described above or would like to report a clinical event, please contact the Boston Scientific RhythmCARE Support team. Adverse events may also be reported directly to the FDA s MedWatch Adverse Event Reporting program. United States RhythmCARE Support 1.800.CARDIAC (227.3422) [email protected]
Recall details
- Recall number
- Z-2049-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 30, 2026
- Posted by the FDA
- May 1, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 148 units
- Product code
- MXD
- FDA submissions
- K231328
- Distribution
- Worldwide distribution - US Nationwide and the country of Belgium.
Product description
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
LUX-Dx II Plus UDI-DI: 00802526620706 (US), 00802526623707 (EU/AU); SERVER SW LATITUDE DRAGON EU UDI-DI: 00802526613821; SERVER SW LATITUDE DRAGON AU UDI-DI: 00802526613814; Serial Number: 100085 100676 100909 100944 101811 102341 102405 102864 102956 102978 103018 105283 105697 106372 106429 106690 107386 107460 108132 108429 108433 108641 108697 108805 108861 108901 109663 109699 109836 110700 110737 110858 111048 111119 111269 111290 111362 111780 111987 112265 112549 113400 113495 113720 114072 114393 115310 115411 115835 115862 115890 115981 116066 116090 116197 117180 117533 117560 117820 117924 117960 119462 120931 121080 121203 121267 121483 122855 123305 123412 124378 124458 124557 124791 124987 125008 126249 127182 127441 127758 127821 128106 128506 129528 129763 129782 130474 131469 132487 132549 133195 133786 133989 134600 135362 136038 136746 136884 137047 137134 137319 137449 138039 138059 138334 138759 139080 139165 140319 141181 142273 143441 143887 144590 144777 145284 145336 145684 146709 147185 147618 148972 149028 153330 153628 155199 155735 155898 156145 156895 157872 158926 159162 160236 160471 160615 161307 161762 162801 162821 163556 163802 167866 169673 169701 171284 172766 175538
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LUX-Dx II+™ 60M312-100Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall429 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98679).
- Z-2048-2026 · Open, ClassifiedLUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page