Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 88175
Description: Medtronic Reveal LINQ LNQ11 / PA96000
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 88175 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2102-2021 |
| Event ID | 88175 |
| Event Description | Medtronic Reveal LINQ LNQ11 / PA96000 |
| Product Type | Devices |
| Distribution | Worldwide Distribution |
| Quantity | 666210 devices |
| Recall 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. |
| Device Classification | 20210728 |
| Device 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 |
| Center Classification Date | 20210720 |
| Recall Initiation Date | 20210601 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
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