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FDAFDA · Food and drugs·Recall number Z-1123-2022

Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.

Published June 1, 2022 · Recall initiated: March 30, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medtronic Neuromodulation
Distributor
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, Germany, Switzerland, Ireland, Croatia, Norway.
Lot
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: 10/28/2023; Serial Number: NMS502726H Expiration Date: 11/28/2023; Serial Numbers: NMS503047H, NMS503048H, NMS503049H, NMS503050H, NMS503051H, NMS503052H, NMS503053H, NMS503055H, NMS503056H, NMS503057H, NMS503058H Expiration Date: 12/14/2023; Serial Numbers: NMS503250H, NMS503252H, NMS503257H, NMS503266H, NMS503267H 2) GTIN/UPN: 00763000478087: Expiration Date: 02/28/2023; Serial Numbers: NMS500093H, NMS500094H, NMS500095H, NMS500097H, NMS500098H, NMS500099H, NMS500100H, NMS500101H, NMS500102H, NMS500103H, NMS500104H, NMS500105H, NMS500106H, NMS500107H, NMS500108H, NMS500109H, NMS500110H, NMS500111H, NMS500112H, NMS500113H, NMS500115H, NMS500116H, NMS500117H, NMS500118H, NMS500119H Expiration Date: 03/14/2023; Serial Numbers: NMS500121H, NMS500124H, NMS500125H, NMS500126H, NMS500127H, NMS500128H, NMS500129H, NMS500131H, NMS500132H, NMS500133H, NMS500134H, NMS500136H, NMS500137H, NMS500138H, NMS500139H, NMS500140H, NMS500141H, NMS500142H, NMS500143H, NMS500144H, NMS500145H, NMS500146H, NMS500147H, NMS500148H, NMS500149H, NMS500150H, NMS500151H, NMS500152H, NMS500153H, NMS500154H, NMS500155H, NMS500156H, NMS500157H, NMS500158H, NMS500160H, NMS500161H, NMS500162H, NMS500163H, NMS500164H, NMS500165H, NMS500166H, NMS500167H, NMS500168H, NMS500169H, NMS500170H, NMS500171H, NMS500172H, NMS500173H, NMS500174H, NMS500175H, NMS500176H, NMS500177H, NMS500178H, NMS500179H, NMS500181H, NMS500182H, NMS500183H, NMS500184H, NMS500185H, NMS500186H, NMS500187H, NMS500188H, NMS500189H, NMS500192H, NMS500193H, NMS500195H, NMS500196H, NMS500197H, NMS500198H, NMS500199H, NMS500200H, NMS500203H, NMS500204H, NMS500205H, NMS500206H, NMS500207H, NMS500208H, NMS500209H, NMS500210H, NMS500211H, NMS500212H, NMS500213H, NMS500215H, NMS500216H, NMS500217H, NMS500218H, NMS500219H, NMS500220H, NMS500221H, NMS500222H, NMS500223H, NMS500224H, NMS500225H, NMS500226H, NMS500227H, NMS500228H, NMS500229H, NMS500230H, NMS500231H, NMS500232H, NMS500233H, NMS500234H, NMS500235H, NMS500237H, NMS500238H, NMS500239H, NMS500241H, NMS500242H, NMS500244H, NMS500245H, NMS500246H, NMS500247H, NMS500249H, NMS500250H, NMS500251H, NMS500252H, NMS500254H, NMS500255H, NMS500256H, NMS500257H, NMS500258H, NMS500259H, NMS500260H, NMS500263H, NMS500264H Expiration Date: 07/28/2023; Serial Number: NMS501474H Expiration Date: 08/14/2023; Serial Numbers: NMS501602H, NMS501606H Expiration Date: 08/28/2023; Serial Numbers: NMS501610H, NMS501611H, NMS501613H, NMS501617H, NMS501618H, NMS501632H, NMS501633
Risk classification
Class II
Area (FDA)
device
Country
United States

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