Device Recall Medtronic Bravo pH Capsule with Delivery System

  • Model / Serial
    No devices are being returned. The field action is being done to communicate and emphasize the current Instrucitons for Use (IFU) regarding detachment of the Capsule from the Delivery System.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- USA states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan , Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Portugal, Russian Federation, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source