Single Chamber Temporary External Pacemaker, Model 53401

FDA device recall Z-2317-2018 · posted 2018-06-29 · Terminated

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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).

Action taken

Medtronic began notifying customers, via letter, on about 06/06/2018. Customers were instructed to verify if they possessed affected 53401 EPGs, if they did have affected EPGs to determine if the firmware was updated, to notify all appropriate personnel, to notify customers if the affected devices have been transferred, and to complete and return the Customer Confirmation Certificate. Instructions for determining if the EPG firmware has been updated include: 1) powering the unit on and viewing firmware version; 2) if the firmware version is 01.03.00 or greater, the EPG firmware has been updated with the correction; and 3) if firmware version is 01.02.00, the EPG firmware has not been updated. Medtronic requests that customers arrange to have their EPGs returned for the firmware update.

Root cause

Device Design

Status

Terminated

Product code

DTE

Quantity affected

1,108 devices

Distribution

Domestic distribution to 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,

Date initiated

2018-06-06

Date posted

2018-06-29

Date terminated

2021-08-13

Location

Mounds View, MN

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