FDA recall Z-2317-2018

Product

Single Chamber Temporary External Pacemaker, Model 53401

Reason for recall

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).

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 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.

Key facts

Status

Terminated

Initiation date

2018-06-06

Report date

2018-07-04

Termination date

2021-08-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2317-2018