CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

LUX-Dx II Plus, Arrythmia detector and alarm recalled

Boston Scientific is recalling LUX-Dx II Plus, Arrythmia detector and alarm, distributed nationwide in the US. The recall was initiated on 30 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLUX-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

Quantity recalled148 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2049-2026
FDA event ID: 98679
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 30 Mar 2026
FDA classified: 1 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

30 Mar 2026	Recall initiated by company
1 May 2026	Classified by FDA	+32 days
13 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the country of Belgium.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the country of Belgium.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98679

This product is part of a recall event; the main page for the event is Lux-dx II, Arrythmia detector and alarm recalled by Boston Scientific.

Reported	Class	Recall	Company	Reason	Where
13 May 2026	CLASS II	Lux-dx II, Arrythmia detector and alarm recalled by Boston Scientific	Boston Scientific	Device Malfunction	Nationwide

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