Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Single Chamber Temporary External Pacemaker, Model 53401

Recall date

June 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2317-2018

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Sold / distributed

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…

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Single Chamber Temporary External Pacemaker, Model 53401