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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Single Chamber Temporary External Pacemaker, Model 53401
Recalled July 4, 2018 · FDA recall Z-2317-2018 · 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). · FDA Class II
Units
1,108 devices
Sold at
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.
Description
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).
Product
Single Chamber Temporary External Pacemaker, Model 53401
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →