FDA Device recall Z-2102-2021
Medtronic Reveal LINQ LNQ11 / PA96000
- FDA Device
- Class II
- ongoing
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Medtronic Reveal LINQ LNQ11 / PA96000 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 clinic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2102-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-01 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Medtronic Reveal LINQ LNQ11 / PA96000
Reason
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.
Identifiers
| code_info | All serial numbers distributed on or after February 23, 2017 GTIN: 643169845763, 643169845770, 643169845787, 643…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2102-2021%22
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