Recall Z-2317-2018— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Name: FDA recall Z-2317-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-06

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2018-06-06, terminated 2021-08-13. It names one FDA 510(k) clearance: K162054. Product: Single Chamber Temporary External Pacemaker, Model 53401. Reason: A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR)..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Classification: Class II
Status: Terminated
Initiated: 2018-06-06
Terminated: 2021-08-13
Firm location: Mounds View, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K162054 — Medtronic Temporary External Pacemaker 53401Medtronic, Inc.·cleared 2016-10-18

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

Single Chamber Temporary External Pacemaker, Model 53401

Reason for recall

A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR).

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