Medtronic Single Chamber Temporary External Pacemaker Model 53401 May Revert Settings
Medtronic recalls Model 53401 Single Chamber Temporary External Pacemakers with specific serial numbers due to potential power reset causing setting reversion during patient use.
Use caution until it’s fixed
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).
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/70897-medtronic-single-chamber-temporary-external-pacemaker-model-53401-may-revert.
Source Summary by GovInfoNow · govinfonow.com/recall/70897-medtronic-single-chamber-temporary-external-pacemaker-model-53401-may-revert · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2317-2018
Cite this page
“Medtronic Single Chamber Temporary External Pacemaker Model 53401 May Revert Settings.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70897-medtronic-single-chamber-temporary-external-pacemaker-model-53401-may-revert. Based on FDA recall #Z-2317-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2317-2018%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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).
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Device Serial Number
Identify your device's serial number to confirm if it's in the recall list of specific serial numbers.
Contact Medtronic
Reach out to Medtronic directly for guidance on next steps if your device is affected.
Where it went and when
Where it was distributed
Distributed in 44 states and D.C., and outside the U.S.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2317-2018 (June 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2317-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.