FDA Device recall Z-2317-2018

Single Chamber Temporary External Pacemaker, Model 53401

FDA Device
Class II
terminated
Published 2018-07-04

On 2018-07-04 the FDA classified a Class II recall of Single Chamber Temporary External Pacemaker, Model 53401 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 unexp….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2317-2018
Classification	Class II
Status	terminated
Initiated	2018-06-06
Published	2018-07-04
Last updated	2026-09-13 11:54 UTC
Company	Medtronic Cardiac Rhythm And Heart Failure Crhf
Distribution	AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV

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).

Identifiers

code_info	Serial Numbers MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013… Serial Numbers MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013EP, MDB01014EP, MDB01015EP, MDB01016EP, MDB01017EP, MDB01018EP, MDB01019EP, MDB01036EP, MDB01037EP, MDB01038EP, MDB01039EP, MDB01040EP, MDB01041EP, MDB01042EP, MDB01043EP, MDB01044EP, MDB01045EP, MDB01046EP, MDB01047EP, MDB01048EP, MDB01049EP, MDB01050EP, MDB01051EP, MDB01052EP, MDB01053EP, MDB01054EP, MDB01055EP, MDB01056EP, MDB01057EP, MDB01058EP, MDB01060EP, MDB01061EP, MDB01062EP, MDB01063EP, MDB01064EP, MDB01065EP, MDB01066EP, MDB01067EP, MDB01068EP, MDB01069EP, MDB01070EP, MDB01071EP, MDB01072EP, MDB01073EP, MDB01074EP, MDB01075EP, MDB01076EP, MDB01077EP, MDB01078EP, MDB01079EP, MDB01080EP, MDB01081EP, MDB01082EP, MDB01083EP, MDB01084EP, MDB01085EP, MDB01086EP, MDB01087EP, MDB01088EP, MDB01089EP, MDB01090EP, MDB01091EP, MDB01092EP, MDB01093EP, MDB01094EP, MDB01095EP, MDB01096EP, MDB01097EP, MDB01098EP, MDB01099EP, MDB01100EP, MDB01101EP, MDB01102EP, MDB01103EP,

code_info

Serial Numbers MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013…

Serial Numbers MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013EP, MDB01014EP, MDB01015EP, MDB01016EP, MDB01017EP, MDB01018EP, MDB01019EP, MDB01036EP, MDB01037EP, MDB01038EP, MDB01039EP, MDB01040EP, MDB01041EP, MDB01042EP, MDB01043EP, MDB01044EP, MDB01045EP, MDB01046EP, MDB01047EP, MDB01048EP, MDB01049EP, MDB01050EP, MDB01051EP, MDB01052EP, MDB01053EP, MDB01054EP, MDB01055EP, MDB01056EP, MDB01057EP, MDB01058EP, MDB01060EP, MDB01061EP, MDB01062EP, MDB01063EP, MDB01064EP, MDB01065EP, MDB01066EP, MDB01067EP, MDB01068EP, MDB01069EP, MDB01070EP, MDB01071EP, MDB01072EP, MDB01073EP, MDB01074EP, MDB01075EP, MDB01076EP, MDB01077EP, MDB01078EP, MDB01079EP, MDB01080EP, MDB01081EP, MDB01082EP, MDB01083EP, MDB01084EP, MDB01085EP, MDB01086EP, MDB01087EP, MDB01088EP, MDB01089EP, MDB01090EP, MDB01091EP, MDB01092EP, MDB01093EP, MDB01094EP, MDB01095EP, MDB01096EP, MDB01097EP, MDB01098EP, MDB01099EP, MDB01100EP, MDB01101EP, MDB01102EP, MDB01103EP,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2317-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.