Medtronic Reveal LINQ LNQ11 / PA96000
This recall is currently active, issued June 1, 2021. It was issued by Medtronic Inc., Cardiac Rhythm And Heart Failure (Crhf).
- Recall Initiated
- June 1, 2021
- Recall Number
- Z-2102-2021
- Quantity
- 666210 devices
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
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
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
Root Cause
Software design
Action Taken
The firm began notifying their consignees on 06/02/2021 by letter. The letter explained the issue, provided patient management recommendations, and reported that a software update was anticipated in late 2021. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-929-4043.