medical Class II Updated 2021-07-28

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Reveal LINQ LNQ11 / PA96000

Recalled Product

Medtronic Reveal LINQ LNQ11 / PA96000


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide Distribution
Lot/Code Info: All serial numbers distributed on or after February 23, 2017 GTIN: 643169845763, 643169845770, 643169845787, 643169845794, 643169845800, 643169845817, 643169845824, 00643169845831, 00643169845848, 00643169845855, 00643169845862, 00643169845879, 00643169845893, 00763000188382, 00763000188399, 00763000188405, 00763000188412, 00763000188429, 00763000188436, 00763000188443, 00763000188450, 00763000188467, 643169845688, 643169845695, 643169845701, 643169845718, 643169845732, 643169845749, 643169845756
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