Medtronic LINQ Heart Monitor recallZ-2102-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Jun 1, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2102-2021
- Status
- Open, Classified
- Initiated by the company
- Jun 1, 2021
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 666210 devices
- Product code
- MXD
- FDA submissions
- K162855
- Distribution
- Worldwide Distribution
Product description
Medtronic Reveal LINQ LNQ11 / PA96000
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Reveal LINQ™ LNQ11Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA1 recall7,581 reports
- Reveal LINQ™ LNQ11Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA1 recall343 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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