FDA-Device2018-07-04Class II
Single Chamber Temporary External Pacemaker, Model 53401
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
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).
Sold states
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, Finland, France, Germany, India, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Nepal, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Sierra Leone, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Turkey, United Arab Emirates, United Kingdom.
Affected count
1,108 devices
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Single Chamber Temporary External Pacemaker, Model 53401
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2317-2018Don't want to check this manually?
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