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Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable n

Recalled August 31, 2022 · FDA recall Z-1571-2022 · Medtronic Neuromodulation

Hazard
Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable Neurostimulator (INS) Model 977006. · FDA Class II
Units
2,920 downloaded software applications
Sold at
Worldwide distribution - US Nationwide distribution including in the 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. The countries of Austria, Belgium, Canada, Canary Islands, Cayman Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

Description

Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable Neurostimulator (INS) Model 977006.

Product
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Manufacturer(s)
Medtronic Neuromodulation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov