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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