Medtronic Reveal LINQ LNQ11 / PA96000 — Class II medical device recall Z-2102-2021
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2021-07-28. Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are
| Recall number | Z-2102-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2021-06-01 |
| Classified | 2021-07-20 |
| Reported by FDA | 2021-07-28 |
| Quantity | 666,210 devices |
| UPC / GTIN / UDI-DI | 00643169845688, 00643169845695, 00643169845701, 00643169845718, 00643169845732, 00643169845749, 00643169845756, 00643169845763, 00643169845770, 00643169845787, 00643169845794, 00643169845800, 00643169845817, 00643169845824, 00643169845831, 00643169845848, 00643169845855, 00643169845862, 00643169845879, 00643169845893, 00763000188382, 00763000188399, 00763000188405, 00763000188412, 00763000188429 and 4 more |
Product
Medtronic Reveal LINQ LNQ11 / PA96000
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2102-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.