Z-2076-2021Class II

Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only

Name: Z-2076-2021 Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-05-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-05-14 / Open, Classified / root cause: software

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only on 2021-05-14. FDA classified it as Class II and gives the reason as "Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset". 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-2076-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-14
Posted: 2021-07-14
Recalling firm: Medtronic, Inc.
Product: Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Product code: MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Reason for recall: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
Root cause tag: software
FDA root cause: Software design
Action: On June 1 2021 Medtronic sent a letter notifying the consignees the following: -LINQ II insertable cardiac monitors (ICM) that undergo a partial electrical reset appear to be programmed ON, but are no longer able to detect and report Brady, Pause, and PVC events to clinicians. Medtronic estimates that 0.21% of LINQ II ICMs have experienced a partial electrical reset resulting in the inability to detect Brady, Pause, and PVC events. -A correction for currently implanted LINQ II ICMs is not available. -We are requesting that hospitals quarantine all LINQ II ICMs on hospital shelves. Physicians should cease implanting any remaining LINQ II ICMs that may remain in shelf stock and return any unused product to Medtronic. -There will be an update for future manufactured LINQ II ICMs, which is anticipated to be available in the U.S. July 2021. UPDATE: On June 16 2021, the firm sent an updated letter to inform their consignees of the availability of LINQ II Insertable Cardiac Monitors (ICMs) with an FDA cleared update addressing the issue referenced in the June 2021 letter. Updated LINQ II ICMs will not be susceptible to the potential for disabled Brady, Pause, and PVC detection after a partial electrical reset. Note that: - Initial supply of the updated LINQ II ICMs may be limited. - LINQ II ICMs manufactured prior to the approval of this update cannot be corrected in the field. ---- LINQ II ICMs implanted prior to the release of this update will continue to be susceptible to this issue. - Please continue to return all unused, affected LINQ II ICMs in your inventory to Medtronic. Contact Customer Service at 1-800-848-9300, or your local Medtronic Representative to assist you with a product return. UPDATE: On 08/02/2023, Medtronic sent another notification advising consignees of the availability of a software update for identified LINQ II ICMs.
Quantity in commerce: 21,685
Distribution: Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Model Number: LNQ22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2076-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2076-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-14

Product code MXD

K200795Class IILINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMedtronic, Inc. / cleared 2020-07-03

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)