Medtronic recalls Model 53401 Single Chamber Temporary External Pacemakers with specific serial numbers due to potential power reset causing setting reversion during patient use.
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).
Medtronic is recalling certain Model 53401 Single Chamber Temporary External Pacemakers that may revert from programmed settings to nominal settings during patient use due to an unexpected Power on Reset. This could affect the device's ability to properly manage heart rhythms.
The device may unexpectedly reset from programmed settings to nominal settings during patient use due to a Power on Reset (POR) issue. This could cause the pacemaker to function incorrectly, potentially leading to improper heart rhythm management.
Patients using the recalled Model 53401 Single Chamber Temporary External Pacemakers with specific serial numbers are most at risk. The device may revert settings during use, potentially affecting heart rhythm management.
Check if your device has the Model 53401 Single Chamber Temporary External Pacemaker with serial numbers listed in the recall (e.g., MDB01005EP through MDB04029UP).
Identify your device's serial number to confirm if it's in the recall list of specific serial numbers.
Reach out to Medtronic directly for guidance on next steps if your device is affected.
The specific model is Medtronic Model 53401 Single Chamber Temporary External Pacemaker.
The recall includes specific serial numbers from MDB01005EP through MDB04029UP as listed in the record.
The recall states the device may revert settings during use, but does not specify a risk of serious injury. The hazard mechanism is potential setting reversion, not immediate harm.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2317-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2317-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
