LINX Reflux Device Failed Due to Manufacturing Defect, Lawsuit Alleges

Multiple lawsuits have been brought against the manufacturers of LINX acid reflux systems, following a 2018 recall of more than 9,000 devices.

A Texas man claims he was implanted with a defective, and now-recalled LINX device, which required him to undergo additional surgery earlier this month to remove it.

The complaint (PDF) was filed by Larry Price in the U.S. District Court for the District of Minnesota on November 18, naming Torax Medical Inc. and Ethicon Inc. as defendants.

Originally developed by Torax, which was acquired by Johnson & Johnson subsidiary Ethicon in 2017, the LINX device consists of a bracelet-like ring of magnetic beads connected by thin titanium wires. Surgeons implant the system around the lower esophageal sphincter (LES) to prevent stomach acid from flowing backward, the underlying cause of gastroesophageal reflux disease (GERD), which commonly affects older adults.

LINX Device Recall

Although the LINX Reflux Management System was promoted as a safe option for individuals with chronic GERD who do not respond well to proton pump inhibitors (PPIs), a growing number of recipients have reported incidents of the magnetic beads separating from the connecting wires.

In May 2018, the U.S. Food and Drug Administration (FDA) announced a LINX implant recall for approximately 9,131 devices after determining that a manufacturing issue may cause the titanium beads to detach, which could result in device migration, punctured organs and other injuries.

Since then, a number of LINX recall lawsuits have been filed by those who suffered complications, including migration of the device into the esophagus or the need for revision surgeries to remove broken implants.

Price’s lawsuit claims the LINX Reflux Management System implanted in him is an FDA-restricted device that received premarket approval in 2012, placing strict requirements on how it must be manufactured, distributed and monitored. After the device entered clinical use, Price underwent implantation on October 28, 2016.

According to the complaint, the device implanted in Price was later identified as part of a May 2018 Class II recall, issued roughly two years after his surgery, when Torax determined that certain LINX models had been manufactured “out of specification.” The defect allowed bead components to separate from the adjacent titanium wire links, causing the normally continuous ring to break open.

The filing states that Torax and Ethicon subsequently acknowledged that Price’s implant exhibited the same manufacturing defect flagged in the recall. As the device began to separate, Price experienced a severe return of his GERD symptoms, ultimately leading to an invasive removal surgery on November 7, 2025.

Price alleges that the LINX system was manufactured in violation of multiple FDA quality-system and process-control regulations, resulting in a device that did not conform to the specifications approved under its premarket approval.

In addition, the complaint emphasizes that Ethicon’s role extended beyond acquiring Torax in 2017. Price asserts that Ethicon participated in the manufacturing, distribution and post-market surveillance of the LINX system and therefore shares responsibility for ensuring that the device met FDA-approved standards and was not placed into commerce in a defective condition.

“As a result of Defendant Torax’s violations of federal regulation, approved-manufacturing process, and manufacturing standard of care, Plaintiff’s LINX was defectively manufactured and failed as a result of that defect. At the time the LINX device left the control of Defendant Torax, it was outside of manufacturing specification and was unreasonably dangerous due to its defective manufacture.”

— Larry Price v. Torax Medical Inc. and Ethicon Inc.

The lawsuit raises allegations of strict liability, negligence, and negligence per se against both defendants. Price is seeking damages for medical care and expenses, lost wages, physical pain and suffering, mental anguish, physical impairment, and disfigurement.

LINX Reflux Device Lawsuits

Following the manufacturer’s removal of LINX devices from certain foreign markets in September 2025, concerns are mounting that additional implant recipients may experience device breakages which could result in long-term or permanent harm.

Given the severity of the reported failures, attorneys are evaluating new LINX-related injury cases and seeking compensation for patients who suffered complications such as:

• LINX device breakage or failure
• Device migration
• Organ punctures or abrasions
• Surgical removal or revision procedures
• Other injuries linked to malfunctioning LINX implants

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