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Advanced Neuromodulation Systems

Also registered as Advanced Neuromodulation System, Inc, Advanced Neuromodulation Systems, Inc. (Ans Inc.)

Country not established

Advanced Neuromodulation Systems is a medical device manufacturer, with 90 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class III, II and I) and 10 FDA recalls as of 12 Nov 2026.

Devices
90
FDA recalls
10

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 63
  • FDA 510(k) 27
  • EUDAMED 18

A device listed in two registries counts in both.

Device classes
  • FDA Class III 58
  • FDA Class II 30
  • FDA Class I 2
FDA recalls

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Advanced Neuromodulation Systems makes

Advanced Neuromodulation Systems manufactures implantable and external devices for neuromodulation therapy, including spinal cord and peripheral nerve stimulation leads (e.g., Lamitrode®, Octrode®, Quattrode®), deep brain stimulation systems (e.g., NeuroSphere™), and reusable pin-indexed adaptors (e.g., Penta™). The company also produces multiple active implantable device programmers (e.g., SJM™, Proclaim™) and noninvasive battery chargers for these systems. These products are designed for chronic pain management and neurological conditions.

The company’s devices are classified under FDA regulations as Class II and Class III, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue90

Newest first, rows 1-50 of 90

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  • MN13650

    Active Regimes: PMA Registry: GUDID Class:III

  • 1210 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Infinity™ 6884 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Proclaim™ 3884 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Proclaim™ 7884

    Active Regimes: PMA Registry: GUDID Class:III

  • Lamitrode® 3244 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • 66000 Open recall

    Expiring Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • 1291 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Lamitrode® 3288 Open recall

    Expiring Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Lamitrode® 3268 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • 3042 Open recall

    Expiring Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Sjm™ 3701 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Proclaim™ 3884 Open recall

    Active Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Eon Mini™ 3719 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Quattrode® 3159 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Penta™ 3228 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • SlimTip™ MN10350-90A

    Active Regimes: PMA Registry: GUDID Class:III

  • Lamitrode® 3246 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Quattrode® 3153 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • 1120

    Expiring Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Octrode® 3186 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • NeuroSphere™ 3876 Open recall

    Active Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Lamitrode® 3266 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Eon Mini™ 3721 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Lamitrode® 3243 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Lamitrode® 3262 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • 1210 Open recall

    Active Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Eon Mini™ 3720 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Octrode® 3183 Open recall

    Expiring Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Quattrode® 3141 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Exclaim™ 3224 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Lamitrode Tripole™ 3219 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Quattrode™ 3066

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 12710 Open recall

    Active Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Sjm™ 3870 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Eon Mini™ 3722 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • SlimTip™ MN10450-90A

    Active Regimes: PMA Registry: GUDID Class:III

  • 16760 Open recall

    Active Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Quattrode® 3143 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • 7885

    Active Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Quattrode® 3161

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Liberta RC™ 62400 Open recall

    Expiring Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • Lamitrode® 3240 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Sjm™ 3871 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Lamitrode® 3286 Open recall

    Expiring Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

  • NA Communication Wand Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • 3009

    Active Regimes: 510(k) Registry: GUDID Class:II

  • 1280 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Eon™ 3716 Open recall

    Active Regimes: PMA Registry: GUDID Class:III

  • Quattrode® 3146 Open recall

    Expiring Regimes: CE MDR PMA Registry: EUDAMEDGUDID Class:III

Rows 1-50 of 90

Showing 1-50 of 90

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 10 recalls initiated by Advanced Neuromodulation Systems, the earliest on 2006-12-22 and the most recent on 2012-09-04. By recorded status: 10 terminated. The reasons filed fall into these groups: software or firmware, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2012

    • 4 Sep 2012 Z-0025-2013 Class II Terminated Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board. Distribution: US Nationwide Distribution Submission number: P010032
    • 28 Mar 2012 Z-0894-2013 Class II Terminated Unintended Fluid ingress into the device header has been shown. Distribution: Worldwide Distribution - 53 consignees out of the US.

  • 2011

    • 19 Dec 2011 Z-1983-2012 Class II Terminated The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin Distribution: Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada,…
      Full distribution text Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
      Submission number: P010032S023
    • 19 Dec 2011 Z-2280-2012 Class II Terminated As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively. Distribution: Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia,…
      Full distribution text Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
      Submission number: P010032S014
    • 19 Dec 2011 Z-2281-2012 Class II Terminated As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively. Distribution: Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia,…
      Full distribution text Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
      Submission number: P010032S023
    • 24 May 2011 Z-2607-2011 Unclassified (pre-2012) Terminated Defective battery was identified as cause for reports of inability to communicate or recharge the product. Distribution: Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL,…
      Full distribution text Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.
      Submission number: P010032S023

  • 2010

    • 23 Apr 2010 Z-1599-2010 Unclassified (pre-2012) Terminated Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability. Distribution: Nationwide Distribution -- GA, NC, CA, OK, SC and NJ. Submission number: P010032-S023
    • 22 Feb 2010 Z-1425-2010 Unclassified (pre-2012) Terminated Directions For Use of product incorrectly stated lead compatibility information. Distribution: Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND…
      Full distribution text Nationwide distribution: AZ, CA, CO, DC, FL, GA, IL, IN, MI, MO, MS, NC, NM, NJ, NV, NY, OH, OK, OR, PA, SC, TN, WA AND WV.
      Submission number: K092371

  • 2009

    • 2 Jun 2009 Z-3091-2011 Unclassified (pre-2012) Terminated Product programmed with unapproved software was distributed. Distribution: Distributed in New Hampshire and Puerto Rico. Submission number: P010032

  • 2006

    • 22 Dec 2006 Z-0170-2010 Unclassified (pre-2012) Terminated Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system. Distribution: Worldwide Submission number: P010032/S14/

Frequently asked questions

How many devices does Advanced Neuromodulation Systems have in the registry?

The registry currently lists 90 devices for Advanced Neuromodulation Systems. Devices recorded under merged duplicate company entries are counted once.

Which registries list Advanced Neuromodulation Systems's devices?

Among its 50 most recently registered devices, Advanced Neuromodulation Systems has devices listed in EUDAMED (14 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Advanced Neuromodulation Systems's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Advanced Neuromodulation Systems's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Advanced Neuromodulation Systems?

FDA recall records list 10 recalls initiated by Advanced Neuromodulation Systems, the most recent initiated on 4 Sep 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Advanced Neuromodulation Systems in the registry?

The most recently registered devices listed for Advanced Neuromodulation Systems include MN13650, 1210, Infinity™ 6884 and Proclaim™ 3884.

Generated automatically from registry data and not verified by a human reviewer.