Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Single Chamber Temporary External Pacemaker Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to A subset of Medtronic Model 53401 Single Chamber...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.
Affected Products
Single Chamber Temporary External Pacemaker, Model 53401
Quantity: 1,108 devices
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed to 45 states: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report