Recall Z-2076-2021— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Name: FDA recall Z-2076-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-14

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-05-14. It names one FDA 510(k) clearance: K200795. Product: Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only. Reason: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Classification: Class II
Status: Ongoing
Initiated: 2021-05-14
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

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

Reason for recall

Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

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