Z-2102-2021Class II

Medtronic Reveal LINQ LNQ11 / PA96000

Name: Z-2102-2021 Medtronic Reveal LINQ LNQ11 / PA96000
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-06-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-06-01 / Open, Classified / root cause: software

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Medtronic Reveal LINQ LNQ11 / PA96000 on 2021-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2102-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-01
Posted: 2021-07-20
Recalling firm: Medtronic, Inc.
Product: Medtronic Reveal LINQ LNQ11 / PA96000
Product code: MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 666210 devices
Distribution: Worldwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2102-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2102-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-20

Product code MXD

K162855Class IIReveal LINQMedtronic, Inc. / cleared 2017-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)