MXD

Injury

1,880

Malfunction

9,487

Total

11,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K253516 — Assert-IQ (DM5100) ABBOTT MEDICAL · 2025-12-18
• K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) Abbott · 2025-09-17
• K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) Boston Scientific Corporation · 2025-09-12
• K240693 — LINQ II™ Insertable Cardiac Monitor (ICM) Medtronic, Inc. · 2024-03-28
• K233562 — LINQ II Insertable Cardiac Monitor Medtronic, Inc. · 2023-12-06
• K233320 — LINQ II™ Insertable Cardiac Monitor (LNQ22) Medtronic, Inc. · 2023-10-31
• K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) Boston Scientific Corp · 2023-08-19
• K230375 — BIOMONITOR IV Biotronik, Inc. · 2023-05-19
• K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application Medtronic, Inc. · 2023-04-26
• K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System Medtronic, Inc. · 2023-04-05
• K221962 — LINQ II Insertable Cardiac Monitor Medtronic, Inc. · 2022-08-25
• K221856 — BIOMONITOR IIIm, BIOMONITOR III Biotronik, Inc. · 2022-07-27
• K212008 — Reveal LINQ Insertable Cardiac Monitor Medtronic, Inc. · 2021-07-22
• K210484 — LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System Medtronic, Inc. · 2021-06-11
• K211304 — LINQ II Insertable Cardiac Monitor Medtronic, Inc. · 2021-05-28
• K210608 — LUX-Dx Insertable Cardiac Monitor Boston Scientific Corporation · 2021-05-25
• K201865 — Biomonitor III, Biomonitor IIIm Biotronik, Inc. · 2020-12-08
• K200795 — LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit Medtronic, Inc. · 2020-07-03
• K193473 — LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US Boston Scientific Corporation · 2020-06-26
• K200444 — Biomonitor III, Biomonitor IIIm Biotronik, Inc. · 2020-04-23
• K190548 — BIOMONITOR III, Remote Assistant III Biotronik, Inc. · 2019-07-05
• K171514 — BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set Biotronik, Inc. · 2017-06-29
• K170628 — BioMonitor 2-AF, BioMonitor 2-S Biotronik, Inc. · 2017-03-31
• K162855 — Reveal LINQ Medtronic, Inc. · 2017-02-23
• K163460 — Reveal LINQ Insertable Cardiac Monitor Medtronic, Inc. · 2017-02-14
• K160809 — Reveal LINQ Medtronic, Inc. · 2016-05-26
• K160689 — Reveal LINQ Medtronic, Inc. · 2016-04-22
• K152995 — BioMonitor 2-AF, BioMonitor 2-S Biotronik, Inc. · 2016-04-11
• K150614 — Reveal LINQ Medtronic, Inc. · 2015-08-06
• K143503 — BioMonitor Biotronik, Inc. · 2015-03-19
• K132960 — BIOMONITOR Biotronik, Inc. · 2014-06-06
• K132649 — REVEAL LINQ INSERTABLE CARDIAC MONITOR Medtronic, Inc. · 2014-02-14