The Recall Desk

Manufacturer

Advanced Neuromodulation Systems Inc.

5 recalls in our database name Advanced Neuromodulation Systems Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
3
Most recent
2013-03-06

Of the 5 recalls from Advanced Neuromodulation Systems Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (60%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-0894-2013·2013-03-06

    Brio DBS implantable pulse generators recalled for unintended fluid ingress

    Advanced Neuromodulation Systems Inc. is recalling Brio DBS System Model 6788 implantable pulse generators because unintended fluid ingress into the device header has been shown.

    Product
    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0025-2013·2012-10-17

    Advanced Neuromodulation Systems Recalls Eon Mini Implantable Pulse Generators

    Advanced Neuromodulation Systems is recalling 56 Eon Mini Implantable Pulse Generators manufactured in April 2012 due to a potential internal battery contact issue that could cause painful stimulation surges.

    Product
    The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectron
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2280-2012·2012-09-05

    Advanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints

    Advanced Neuromodulation Systems is recalling Eon IPGs due to reports of warmth or heating at the implant site during charging.

    Product
    Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2281-2012·2012-09-05

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Systems

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation Systems due to reports of warmth or heating at the implant site during charging.

    Product
    The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1983-2012·2012-07-18

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation devices due to a workmanship issue that can cause loss of communication or recharging, resulting in loss of pain relief.

    Product
    Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low b
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ADVANCED NEUROMODULATION SYSTEMS

Source: Wikidata (Q125927525), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.