Medtronic Reveal LINQ LNQ11 / PA96000
Check against the official notice below — it lists the full affected range.
Medtronic Inc. has recalled approximately 666,210 Reveal LINQ insertable cardiac monitors (ICMs) with TruRhythm technology distributed worldwide on or after February 23, 2017. These devices may experience a partial electrical reset that causes them to appear programmed to detect heart rhythm problems, but they actually lose the ability to detect and report Brady events (abnormally slow heart rhythms) and Pause events (interruptions in heart rhythm) to clinicians.
The recall affects devices with specific serial numbers and product codes listed in the recall notice. However, the recall record does not specify what remedy or actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution Quantity: 666210 devices 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.