Recall Z-2317-2018
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated June 6, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Single Chamber Temporary External Pacemaker, Model 53401
Codes / lots: 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, MDB01104EP, MDB01105EP, MDB01106EP, MDB01107EP, MDB01108EP, MDB01109EP, MDB01110EP, MDB01111EP, MDB01112EP, MDB01113EP, MDB01114EP, MDB01115EP, MDB01116EP, MDB01117EP, MDB01118EP, MDB01119EP…
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).
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-2317-2018
- Initiated
- June 6, 2018
- Posted by FDA
- June 29, 2018
- Terminated
- August 13, 2021
- Product code
- DTE – Pulse-Generator, Pacemaker, External
- Quantity
- 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, WV. International distribution to Armenia, Austria, Bangladesh, Belgium, China, Dominican Republic, Finland, France, Germany, India, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Nepal…
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN