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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Reveal LINQ LNQ11 / PA96000
Recalled July 28, 2021 · FDA recall Z-2102-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
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 clinicians. · FDA Class II
Units
666210 devices
Sold at
Worldwide Distribution
Description
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 clinicians.
Product
Medtronic Reveal LINQ LNQ11 / PA96000
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →