Recall Z-0782-2022— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Name: FDA recall Z-0782-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-18

Class II · Completed

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2022-01-18. It names one FDA 510(k) clearance: K200795. Product: LINQ II Insertable Cardiac Monitor. Reason: Devices may lose functionality due to susceptibility to moisture ingress..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Classification: Class II
Status: Completed
Initiated: 2022-01-18
Firm location: Mounds View, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K200795 — LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMedtronic, Inc.·cleared 2020-07-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LINQ II Insertable Cardiac Monitor

Reason for recall

Devices may lose functionality due to susceptibility to moisture ingress.

Data sourced from openFDA. This site is unofficial and independent of the FDA.