Advanced Neuromodulation Systems Inc.

FDA recalling firm · 4 enforcement events · 5 product records · 2011–2012 · TX

Advanced Neuromodulation Systems Inc. has 4 FDA enforcement events on this register (5 product records) between 2011 and 2012: 4 device; the busiest year was 2011 with 2.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in TX.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
4 Sep 2012	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 microelectronic circuitry to generate constant…	Device	Class II	1	Terminated
28 Mar 2012	Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.	Device	Class II	1	Terminated
19 Dec 2011	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 trunk and/or limbs including unilateral or…	Device	Class II	2	Terminated
19 Dec 2011	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 back and leg pain.	Device	Class II	1	Terminated

By type and class

Device4

Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Advanced Neuromodulation Systems Inc. by year initiated.

Questions and answers

How many FDA recalls has Advanced Neuromodulation Systems Inc. had?

4 enforcement events (5 product records) on this register, 2011–2012: 4 device.

Are any Advanced Neuromodulation Systems Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Advanced Neuromodulation Systems Inc. recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.