Boston Scientific Spinal Cord Stimulator Lead Recall Issued After More Than 1,000 Serious Injuries

Spinal cord stimulator lawsuits allege device failures can result in loss of pain relief and require additional surgery to repair, replace or remove the implants.

A Boston Scientific spinal cord stimulator lead recall has been issued after more than 1,000 serious injuries were reported in connection with Infinion CX lead fractures that may result in inadequate stimulation and require additional surgery.

The U.S. Food and Drug Administration (FDA) announced the Infinion CX recall on September 3, indicating problems with the leads may prevent the spinal cord stimulators from providing adequate therapy. The agency identified the action as the most serious type of recall, warning that continued use of affected devices may result in serious injury or death.

Spinal Cord Stimulator Injury Risks

Spinal cord stimulators (SCS) are implanted medical devices used to manage chronic pain when less invasive treatments have not provided adequate relief. The systems typically include a battery-powered pulse generator connected to thin leads containing electrodes that are positioned near the spinal cord, along with an external controller that allows individuals to adjust the stimulation.

Due to how the leads carry electrical signals from the pulse generator to the electrodes, lead fractures, migration or other failures can interfere with stimulation delivered to the targeted area.

Problems involving spinal cord stimulator leads and other components have resulted in a growing number of spinal cord stimulator lawsuits, which allege device failures caused recipients to lose pain relief, suffer additional injuries and undergo procedures to repair, replace or remove their implants.

Individuals have reported spinal cord stimulators that failed to adequately control their pain, as well as complications involving unexpected electrical shocks, burns, migration of the pulse generator or leads from their intended positions and components protruding through the skin. Some lawsuits also allege the devices caused nerve damage and left patients with more severe pain than they experienced before implantation.

Spinal Cord Stimulator Lead Recall

According to federal regulators, Boston Scientific had received 1,081 reports of serious injuries associated with Infinion CX spinal cord stimulator leads as of May 27, but no deaths. The recall involves removing unused Infinion CX leads from locations where they are used or sold and does not call for devices already implanted in patients to be removed.

The company initiated the recall after determining that the SCS lead body may experience mechanical stress at the anchor site, potentially resulting in high impedance or fractures. According to the FDA, these problems can interfere with the electrical stimulation delivered by the device and may require additional medical intervention, including surgery to remove and replace the lead.

The spinal cord stimulator lead recall impacts the following unused Infinion CX Lead Kits:

• Infinion CX 50-centimeter Lead Kit — Model SC-2317-50
• Infinion CX 70-centimeter Lead Kit — Model SC-2317-70

Boston Scientific sent a letter to affected customers on June 17, instructing them to immediately stop using or distributing the affected leads, separate them from other inventory and return them to the manufacturer. Customers were also directed to share the recall notice with health care professionals who use the products and any organizations to which affected systems may have been transferred.

The FDA indicates that patients who already have the affected leads implanted do not require additional monitoring beyond routine clinical follow-up.

Customers who experience adverse reactions, encounter product quality issues or have questions about the recall can contact Boston Scientific at BSCComplaints@bsci.com. Adverse reactions or product quality concerns involving the devices can also be reported through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Spinal Cord Stimulator Lawsuits

In recent years, spinal cord stimulator manufacturers, including Boston Scientific, Abbott Laboratories, Medtronic and Nevro, have faced an increasing number of reports and lawsuits involving devices that allegedly malfunctioned, worsened patients’ pain or caused complications requiring additional surgery or removal.

Given common questions of fact and law raised in claims filed against Boston Scientific throughout the federal court system, those lawsuits have been centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge Josephine L. Staton in the Central District of California. The coordinated proceedings are intended to reduce duplicative discovery, avoid conflicting pretrial rulings and improve efficiency as the cases move toward trial or potential settlements.

The U.S. Judicial Panel on Multidistrict Litigation previously declined to include claims involving Abbott, Nevro or Medtronic in the Boston Scientific proceedings. However, plaintiffs have since filed separate motions seeking to establish an Abbott spinal cord stimulator MDL and a Nevro spinal cord stimulator MDL, which would each consolidate claims against those manufacturers before a single federal judge for coordinated discovery and pretrial proceedings.

The Panel is scheduled to hear oral arguments on September 24, 2026, to determine whether the Abbott and Nevro lawsuits should be consolidated into separate MDLs.

As spinal cord stimulator lawyers continue to investigate potential claims against manufacturers, case evaluations are being conducted for individuals who experienced complications such as:

Individuals who experienced these or similar complications may be eligible to pursue a spinal cord stimulator lawsuit. Free case evaluations are available to determine whether a claim may be viable, with no legal fees or expenses unless compensation is recovered.

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