Z-1574-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- July 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4386 downloaded software applications
Product Description
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Reason for Recall
Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.
Distribution Pattern
Worldwide distribution - US 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, WY 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.
Code Information
Model A71200; Software Version 2.0.2455