Z-0782-2022Class II

LINQ II Insertable Cardiac Monitor

Name: Z-0782-2022 LINQ II Insertable Cardiac Monitor
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2022-01-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-01-18 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of LINQ II Insertable Cardiac Monitor on 2022-01-18. FDA classified it as Class II and gives the reason as "Devices may lose functionality due to susceptibility to moisture ingress". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0782-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-18
Posted: 2022-03-11
Terminated: 2026-05-04
Recalling firm: Medtronic, Inc.
Product: LINQ II Insertable Cardiac Monitor
Product code: MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Reason for recall: Devices may lose functionality due to susceptibility to moisture ingress.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On or around January 18, 2002, in the United States, Medtronic will begin notifying notified customers of the field corrective action and patient management recommendations via 2-day UPS delivery. Consignees were provided with proper patient management recommendations. Consignees are asked to complete and return a confirmation certification confirming they have received the notification. Outside the United States (OUS), communication will begin no later than 18-JAN-2022 using locally approved methods.
Quantity in commerce: 8 devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Product codes and lots: 8 impacted devices with the following Serial number and GTIN 1) Serial RLB035341G (GTIN 00763000060374) 2) Serial RLB051224G (GTIN 00763000060374) 3) Serial RLB059666G (GTIN 00763000060374) 4) Serial RLB061064G (GTIN 00763000060374) 5) Serial RLB061812G (GTIN 00763000060381) 6) Serial RLB066367G (GTIN 00763000060374) 7) Serial RLB091638G (GTIN 00763000060374) 8) Serial RLB122769G (GTIN 00763000554002)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0782-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0782-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-11

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)