Recall Z-2317-2018 ยท DTE Pulse-Generator, Pacemaker, External
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Single Chamber Temporary External Pacemaker, Model 53401
| Date | Jun 29, 2018 (initiated Jun 6, 2018) |
| Status | Terminated |
| 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). |
| Root cause | Device Design |
| Action | 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 up |
| 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 Republ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162054 | Medtronic Temporary External Pacemaker 53401 Medtronic, Inc., Oct 18, 2016 |