Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Check against the official notice below — it lists the full affected range.
Medtronic has recalled 1,021 Vanta INS Implantable Neurostimulator Model 977006 devices with AdaptiveStim Technology and Surescan MRI technology due to a potential communication failure between the implanted device and the clinical programmer and/or patient programmer system. The affected devices were distributed worldwide, including throughout the United States and in Italy, Sweden, the Netherlands, Belgium, the United Kingdom, Japan, Finland, Portugal, Spain, Denmark, and Germany, with specific serial numbers and expiration dates listed in the recall notice.
The source document does not specify a remedy for consumers who have received this device.
Written by software from the official notice below. Not reviewed by a lawyer.
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Reason for recall: The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system. Distribution: Worldwide distribution - US Nationwide distribution in the states of 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, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden, Netherlands, Belgium, United Kingdom, Japan, Finland, Portugal, Spain, Canary Islands, Denmark, Germ Quantity: 1021 devices Lot/code info: Model 977006 1) GTIN/UPN: 00763000518615: Expiration Date: 03/14/2023; Serial Numbers: NMS500202H, NMS500236H, NMS500243H, NMS500248H, NMS500253H, NMS500261H, NMS500262H, NMS500265H, NMS500266H, NMS500267H, NMS500269H, NMS500270H, NMS500271H, NMS500272H, NMS500273H, NMS500274H, NMS500275H, NMS500276H, NMS500277H, NMS500278H, NMS500279H, NMS500280H, NMS500282H, NMS500283H, NMS500285H, NMS500286H, NMS500287H, NMS500288H, NMS500289H, NMS500291H, NMS500292H, NMS500293H, NMS500294H, NMS500295H, NMS500296H, NMS500297H, NMS500298H, NMS500299H, NMS500300H, NMS500301H, NMS500302H, NMS500303H, NMS500304H, NMS500305H, NMS500306H, NMS500307H, NMS500308H Expiration Date: 04/14/2023; Serial Numbers: NMS500493H, NMS500494H, NMS500495H, NMS500496H, NMS500497H, NMS500498H, NMS500499H, NMS500500H, NMS500501H, NMS500502H, NMS500503H, NMS500504H, NMS500505H, NMS500506H, NMS500507H, NMS500508H, NMS500509H, NMS500510H, NMS500511H, NMS500512H Expiration Date: 09/14/2023; Serial Numbers: NMS501860H, NMS501861H, NMS501862H, NMS501863H, NMS501864H, NMS501865H, NMS501866H, NMS501923H, NMS501925H, NMS501926H, NMS501931H, NMS502075H, NMS502076H, NMS502079H, NMS502080H, NMS502083H Expiration Date: 09/28/2023; Serial Numbers: NMS502212H, NMS502215H, NMS502220H Expiration Date: 10/14/2023; Serial Numbers:NMS502474H, NMS502476H, NMS502477H, NMS502478H, NMS502479H, NMS502481H, NMS502482H, NMS502483H, NMS502484H, NMS502530H, NMS502531H, NMS502595H, NMS502596H, NMS502597H, NMS502598H, Expiration Date: 10/28/202
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.