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LINQ II™
MEDTRONIC, INC. · Model LNQ22 · UDI-DI 00763000613747
3
510(k) clearances
12,726
Adverse events (4 deaths)
10
Recalls
12
Facilities
Description
ICM LNQ22 LINQ II PRIME US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | Boston Scientific Corporation | 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 Bu |
| 2026-08-06 | Boston Scientific Corporation | 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 Bu |
| 2026-08-06 | Boston Scientific Corporation | 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 Bu |
| 2026-03-30 | Boston Scientific Corporation | 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 Bradyarrhy |
| 2026-03-30 | Boston Scientific Corporation | 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 Bradyarrhy |
| 2024-09-06 | Boston Scientific Corporation | Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITU |
| 2023-11-03 | Medtronic Inc. | It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is dif |
| 2022-01-18 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Devices may lose functionality due to susceptibility to moisture ingress. |
| 2021-06-01 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinici |
| 2021-05-14 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.