LINX Reflux Management System Lawsuit Alleges Implant Failed, Requiring Surgical Removal

Manufacturers failed to remove existing devices from healthcare facility inventories after a LINX acid reflux system recall was issued, despite knowing the beaded implants were prone to breaking, per lawsuit.

Following reports of widespread problems with LINX Reflux Management Systems, including indications that the devices could break inside patients’ bodies, Torax Medical announced a massive recall in May 2018. However, it appears the manufacturer failed to take steps to make sure the recalled LINX systems were not continuing to be implanted in patients.

According to a complaint (PDF) filed in Minnesota federal court on January 19, Michael Lopez indicates that he was implanted with one of the recalled LINX Reflux Management Systems in December 2018, which failed and needed to be surgically removed last year.

The lawsuit presents product liability claims against Torax Medical Inc. and Ethicon Inc., indicating that the manufacturers released and marketed a defective medical device, and failed to take adequate steps to ensure that previously distributed devices were recalled from healthcare facility inventories.

Broken LINX Reflux Management System Risks

The LINX Reflux Management System was designed by Torax before the company was acquired by Johnson & Johnson’s Ethicon division. The device, released in 2017, consists of a small ring of magnetic beads connected by titanium wires, which surgeons place around the lower esophageal sphincter to help keep stomach acid from washing back into the esophagus, a condition more commonly known as gastroesophageal reflux disease (GERD).

Although LINX was marketed as a safe alternative for patients whose GERD symptoms do not respond to proton pump inhibitors, problems have emerged where the magnetic beads separate from the connecting wires.

Reports of the acid reflux device breaking inside patients’ bodies, as well as serious injuries, complications, and the need for revision surgery to remove the broken implants, resulted in a LINX Reflux Management System breakage recall in 2018. The U.S. Food and Drug Administration (FDA), determined that a manufacturing defect could allow the beads to detach, potentially causing the device to migrate, damage nearby organs or lead to other serious complications.

Following the recall, Lopez is one of about a dozen patients who have brought LINX Reflux Management System lawsuits, alleging that the devices broke inside their bodies, leaving them with devastating injuries after the devices failed. Plaintiffs claim the manufacturer knew or should have known the design was faulty and provided the medical community and patients with a more accurate assessment of the implant’s risks of breaking.

According to Lopez, of Texas, he was implanted with a LINX device in December 2018, unaware that it was one of just over 9,000 items recalled only months before his procedure.

The lawsuit indicates the device failed and had to be surgically removed in September 2025. Lopez blames the failure on the manufacturing defect already highlighted by FDA officials during the recall.

Lopez and other plaintiffs say Torax and Ethicon failed to prevent non-conforming devices from entering the market and violated multiple FDA manufacturing regulations that require adequate testing, inspection and process controls.

“As a result of Defendant Torax’s breach of its duty 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.”

– Michael Lopez v. Torax Medical Inc. et al

The lawsuit presents claims of manufacturing defect, negligence, negligence per se, and seeks compensatory damages.

Broken LINX Acid Reflux Device Lawsuits

Concerns about LINX device breakages have increased since the manufacturer pulled LINX implants from certain foreign markets in September 2025, raising questions about whether more patients may experience failures that could lead to lasting or permanent injuries.

Because of the seriousness of the reported problems, attorneys are now reviewing additional LINX injury claims and pursuing compensation for patients who experienced complications, including:

• The need for revision surgery or removal of the device
• Device breakage or mechanical failure
• Migration of the implant
• Organ punctures or tissue damage