Recall Z-2102-2021— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Name: FDA recall Z-2102-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-01

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-06-01. It names one FDA 510(k) clearance: K162855. Product: Medtronic Reveal LINQ LNQ11 / PA96000. Reason: 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..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Classification: Class II
Status: Ongoing
Initiated: 2021-06-01
Firm location: Mounds View, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K162855 — Reveal LINQMedtronic, Inc.·cleared 2017-02-23

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 Reveal LINQ LNQ11 / PA96000

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.

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