Lower risk Medical device recall · FDA · Published June 1, 2021

Medtronic Reveal LINQ Devices May Not Report Heart Rhythm Events

Medtronic recalls Reveal LINQ LNQ11/PA96000 devices made on or after Feb 23, 2017 that may not detect and report heart rhythm issues to doctors.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2102-2021Medical device Medtronic ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391

✎ GovInfoNow plain-language explainer

Medtronic is recalling Reveal LINQ LINQ devices made on or after February 23, 2017 because some models may not detect and report certain heart rhythm problems to doctors. This could lead to missed medical issues if the device fails to alert clinicians. Read more at govinfonow.com/recall/62441-medtronic-reveal-linq-devices-may-not-report-heart-rhythm-events.

Source Summary by GovInfoNow · govinfonow.com/recall/62441-medtronic-reveal-linq-devices-may-not-report-heart-rhythm-events · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2102-2021

Cite this page

“Medtronic Reveal LINQ Devices May Not Report Heart Rhythm Events.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62441-medtronic-reveal-linq-devices-may-not-report-heart-rhythm-events. Based on FDA recall #Z-2102-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2102-2021%22&limit=1).

The FDA announced on June 1, 2021, that Medtronic Inc. is recalling Reveal LINQ LNQ11 / PA96000 cardiac monitors due to a programming error. The devices may appear to be 'ON' but fail to detect and report Brady and Pause events to clinicians.

How to tell if you have it

Medtronic Reveal LINQ LNQ11 / PA96000
UPC 00643169845688
UPC 00643169845695
UPC 00643169845701
UPC 00643169845718
UPC 00643169845732
UPC 00643169845749
UPC 00643169845756
UPC 00643169845763
UPC 00643169845770
UPC 00643169845787
UPC 00643169845794
UPC 00643169845800
UPC 00643169845817
UPC 00643169845824
UPC 00643169845831

The hazard

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.

Context

GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 29 other recalls on record since 2017-12-19. Other recent recalls of similar products include Medtronic CRT-D DTBC2D1 Implantable Defibrillators (2023-05-10), Medtronic - Cardiac Rhythm and Heart Failure (CRHF) Devices (2022-06-22), and Medtronic C304-HIS Device Recall (2022-04-20). Other recent recalls of similar products include Boston Scientific LUX-DX II Arrythmia Detector Recall (2026-03-30), Boston Scientific LUX-Dx II Plus Model M312 (2026-03-30), and Boston Scientific LUX-Dx Cardiac Monitor System Recall (2026-08-06).

How to tell if you have this one

Check if your device has a serial number starting with 643169845 or 00643169845 or 00763000188. Devices made on or after February 23, 2017 are affected.

Brand
Medtronic
Product
Medtronic Reveal LINQ LNQ11 / PA96000
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for a serial number starting with 643169845, 00643169845, or 00763000188 on the device.

How this recall unfolded

Recall timeline

FDA published this recall 57 days after the firm started it.

Jun 1, 2021Firm started the recall
Jul 20, 2021FDA classified it Class II
Jul 28, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62441-medtronic-reveal-linq-devices-may-not-report-heart-rhythm-events">Medtronic Reveal LINQ Devices May Not Report Heart Rhythm Events (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2102-2021 (June 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2102-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.