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Advanced Neuromodulation Systems Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Advanced Neuromodulation Systems Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Advanced Neuromodulation Systems Inc.

Date Product Reason Class
Sep 4, 2012 The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable,... Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, ... Class II
Mar 28, 2012 Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator... Unintended Fluid ingress into the device header has been shown. Class II
Dec 19, 2011 Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be con... As of 11/30/2011, St. Jude Medical has received 110 patient complaints of war... Class II
Dec 19, 2011 The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rech... As of 11/30/2011, St. Jude Medical has received 110 patient complaints of war... Class II
Dec 19, 2011 Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indica... The firm has received 112 complaints of the Eon Mini IPGs that lost the abili... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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