MXC

Death

4

Injury

758

Malfunction

5,066

Total

5,828

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 →

• K230286 — Assert-IQ™ Insertable Cardiac Monitor ABBOTT MEDICAL · 2023-05-17
• K212206 — Jot Dx Insertable Cardiac Monitor Abbott (St. Jude Medical) · 2021-08-13
• K202876 — Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) · 2020-12-01
• K202888 — Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) · 2020-11-23
• K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) Abbott (St. Jude Medical) · 2020-03-17
• K192593 — Confirm Rx Insertable Cardiac Monitor Abbott · 2019-10-18
• K190295 — Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) · 2019-04-10
• K182981 — Confirm Rx Insertable Cardiac Monitor Abbott · 2019-03-29
• K173232 — myMerlin(TM) Mobile Application Model APP1001 St Jude Medical · 2017-11-02
• K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc. · 2017-09-29
• K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) St. Jude Medical, Inc. · 2014-05-28
• K122161 — SJM CONFIRM St Jude Medical · 2012-11-28
• K122090 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR St. Jude Medical, Cardiac Rhythm Management Divisi · 2012-11-15
• K101968 — SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A St Jude Medical · 2010-09-15
• K091206 — SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL Transoma Medical · 2009-05-18
• K083828 — SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT Transoma · 2009-02-11
• K081365 — SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR St Jude Medical · 2008-08-15
• K073147 — SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 Transoma Medical · 2007-12-03
• K063035 — SLEUTH IMPLANTABLE ECG MONITORING SYSTEM Transnoma Medical, Inc. · 2007-10-01
• K011098 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR Medtronic Vascular · 2001-05-04
• K003667 — REVEAL PLUS INSERTABLE LOOP RECORDER Medtronic Vascular · 2001-02-14
• K994331 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR Medtronic Vascular · 2000-01-21
• K972242 — REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM Medtronic Vascular · 1998-01-16