Case type Defective Medical Devices

Spinal Cord Stimulator Failures

A woman holding her sore lower back.

Lead fracture, device failure or removal surgery after a spinal cord stimulator? Tell us your story.

CBW Law reviews claims from people whose spinal cord stimulator leads, generators or software failed and needed more treatment. Tell Us Your Story. Contacting us does not create an attorney-client relationship.

Tell Us Your Story Call (800) 476-2416

A spinal cord stimulator uses implanted leads and a battery to send pulses that ease chronic pain. Leads can fracture, generators and chargers can fail, and some people need surgery to fix or remove the system. In 2026, federal cases against three stimulator makers were coordinated in separate MDLs. A spinal cord stimulator lawyer looks at device records to separate a malfunction from pain relief that simply faded.

How a spinal cord stimulator works

A spinal cord stimulator treats chronic pain in the back or limbs by sending mild electrical pulses to the spinal cord1. A system usually has:

  • Leads: thin wires with electrodes, placed near the spinal cord
  • A generator: a battery-powered unit implanted under the skin, sometimes rechargeable
  • A remote and charger used by the patient
  • Programming software used by the clinic to set the stimulation

People usually try a temporary trial system first, then have a permanent system implanted if the trial helps. A problem can start in any of these parts, and each leaves different evidence.

Device failure versus loss of benefit

Not every disappointing result is a device failure. A stimulator may stop helping because the pain condition changed or because stimulation simply doesn't work well for that person. That is different from a lead that broke or a generator that stopped working. A review separates three situations:

  • A documented malfunction, such as a fractured lead, high impedance readings or a generator or charging failure
  • A complication, such as infection or a lead that shifted out of place
  • Pain relief that faded without a device problem

Programming and impedance records from the clinic often show which one happened. Impedance is a measure of electrical resistance; an abnormally high reading can point to a broken or damaged lead.

The Infinion CX lead recall

Boston Scientific recalled its Infinion CX leads in 2026. It said the lead body may experience mechanical stress at the anchor site, which may cause high impedance measurements or lead fractures. Abnormal impedance may lead to inadequate stimulation or more procedures, including removing and replacing the lead. As of May 27, 2026, Boston Scientific had reported 1,081 serious injuries and no deaths linked to the issue1.

The scope of that recall is narrow. It removes unused leads from where they are sold or used, and the FDA notice says it does not affect devices that have already been implanted. For people who already have the leads, the company recommended no additional monitoring beyond routine clinical follow-up1. Anyone with symptoms should contact the clinic that manages their stimulator.

Infinion CX recall at a glance

Problem
Stress at the anchor site; high impedance or lead fracture1.
Letter to customers
June 17, 2026.
Scope
Unused leads removed; implanted devices not affected.
Reported
1,081 serious injuries, no deaths, as of May 27, 2026.

Spinal cord stimulator litigation

In 2026, the JPML created three separate MDLs for spinal cord stimulators, one per manufacturer. Its Nov. 2, 2026 report lists2:

Federal spinal cord stimulator MDLs (JPML report, Nov. 2, 2026)
MDLCourt and judgeActions pending
No. 3181, Boston Scientific C.D. Cal., Judge Josephine L. Staton 62
No. 3194, Abbott Laboratories N.D. Ill., Judge Lindsay C. Jenkins 27
No. 3195, Nevro Corporation N.D. Cal., Judge Haywood S. Gilliam, Jr. 24

These MDLs are at an early stage. An MDL coordinates pretrial work for individual cases; it is not a class action, a finding against any company or a settlement3.

Who may have a spinal cord stimulator claim

  • A lead fracture or high impedance documented by the clinic
  • A generator, battery or charging failure
  • Surgery to revise, replace or remove the system
  • Burns, shocks or unexpected stimulation documented by a doctor
  • A recalled component confirmed by model and serial number

Spinal fusion hardware is a different kind of device: see spinal hardware and fusion cage failure.

Who may be responsible

An investigation may look at the maker of the specific leads, generator or software involved, based on the device records and any recall. Placement and programming by a clinic are separate questions.

Filing deadlines for spinal cord stimulator lawsuits

Deadlines depend on your state and on when you learned of the problem and its possible cause. Examples:

  • Arizona: generally two years for personal injury and wrongful death4.
  • California: two years for injury to or death of a person caused by another's wrongful act or neglect5.
  • New York: three years for personal injury6, with a separate rule that runs from discovery for injuries caused by the latent effects of exposure to a substance in the body7.
  • Texas: two years for personal injury and wrongful death8, and most product liability claims must be brought within 15 years of the product's sale9.

When the clock starts can depend on when a person knew, or should have known, about the injury and its possible cause. Rules for minors, wrongful death and claims against public hospitals can differ. A device that was part of an earlier settlement can raise its own questions. Ask a medical device attorney to check the rules for your state early, before records are lost.

Tell Us Your Story →

Records that help a spinal cord stimulator review

Records worth gathering

Device

  • Trial and permanent implant reports
  • Lead and generator models and serial numbers
  • Patient ID card

Function

  • Programming and impedance reports
  • Charging history and error messages
  • Imaging of lead position

Surgery

  • Revision or removal operative reports
  • Any recall or service letters

What happens after you contact CBW Law

How a review works

  1. Tell us what happened

    Share what you remember about the stimulator, the problem and the treatment that followed. You do not need every record first.

  2. We identify the device

    We work to confirm the maker, model and lot or serial number, and whether any recall or safety notice covers it.

  3. We gather records

    With your permission, we request operative reports, imaging, device data and other records from your providers.

  4. We explain what we see

    We tell you what the records show, what questions remain and what options may be open, including deadlines.

Losing pain relief is not, by itself, proof that a stimulator was defective. Device records and what a surgeon found come first.

Plain English

Medical, Health & Insurance

Terms you may see in a spinal cord stimulator case.

Device terms

Lead
A thin wire with electrodes placed near the spinal cord.
Implantable pulse generator
The battery unit that sends the pulses.
Anchor
The piece that holds a lead in place; the site of stress in the Infinion CX recall1.

Problems

Impedance
Electrical resistance in the lead; abnormal readings can signal damage.
Lead migration
A lead moving from where it was placed.

Procedures

Trial
A temporary test of stimulation before a permanent implant.
Explant
Surgery to remove the system.

Questions

Spinal cord stimulator lawsuit questions

Short answers to the questions people ask first.

Does the Infinion CX recall mean my implanted lead must come out?

No. The FDA notice says the recall removes unused leads and does not affect implanted devices. Talk to your clinic about any symptoms.

What does high impedance mean?

It's a high electrical resistance reading that can point to a damaged or broken lead.

Is a stimulator that stopped helping defective?

Not necessarily. Relief can fade without a device problem. A spinal cord stimulator lawyer looks for a documented malfunction.

Is there a spinal cord stimulator class action?

Federal cases are in three MDLs created in 2026, one each for Boston Scientific, Abbott and Nevro. They coordinate individual cases.

Do I need a spinal cord stimulator attorney if my system was removed?

A removal or revision is important evidence. A spinal cord stimulator attorney can review why it happened.

What records show a lead fracture?

Impedance and programming reports, imaging and the revision report.

How long do I have to file a spinal cord stimulator lawsuit?

It depends on your state and on when you learned of the problem and its possible cause.

Should I stop using my stimulator?

Talk to the clinic that manages your device before changing anything.

Which companies make spinal cord stimulators?

Several, including Boston Scientific, Abbott and Nevro. Each device has its own records and history.

What does it cost to contact CBW Law?

Telling us your story costs nothing, and contacting us does not create an attorney-client relationship.

Tell Us Your Story

If your spinal cord stimulator failed and you needed more treatment, a spinal cord stimulator attorney can review what happened.

Tell us what happened. CBW Law will review your information and explain what we see. Submitting information does not establish an attorney-client relationship or guarantee representation.

Tell Us Your Story Call (800) 476-2416

This page is general information about spinal cord stimulators. It is not legal or medical advice and does not create an attorney-client relationship. A recall, a revision surgery or loss of pain relief does not, by itself, establish that a device was defective or that anyone is legally responsible. Do not change or stop your therapy without your doctor's advice. Laws and deadlines differ by state, and no outcome can be promised.

Keep reading

Official resources

Government sources for device recalls, safety notices and reporting.

Government

Medical Device Recalls and Early Alerts, FDA

The FDA's list of serious device recalls.

Government

Report a device problem (MedWatch), FDA

Tell the FDA about a problem with a device.

Government

Infinion CX lead recall, FDA

What the recall covers.

Court

Pending MDLs, JPML

Current federal MDL statistics.

Apparatus

Sources & Cited Articles

The source material behind each factual, medical and legal statement on this page, numbered to match the markers in the text.

  1. Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX LeadsU.S. Food and Drug Administration · FDA recall notice, content current as of Sept. 3, 2026; verified Nov 12, 2026Removal of unused Infinion CX leads; does not affect implanted devices; mechanical stress at the anchor site may cause high impedance or lead fracture; 1,081 serious injuries reported as of May 27, 2026; routine follow-up only.
  2. Pending MDL Dockets by Actions Pending (report date Nov. 2, 2026)United States Judicial Panel on Multidistrict Litigation · JPML statistics report; verified Nov 12, 2026Lists each pending MDL with its court, judge, actions pending and total actions.
  3. About the PanelUnited States Judicial Panel on Multidistrict Litigation · JPML; verified Nov 12, 2026Centralizes federal cases sharing common questions of fact for coordinated pretrial proceedings; cases not resolved are remanded.
  4. A.R.S. § 12-542Arizona State Legislature · Arizona Revised Statutes; verified Nov 12, 2026Two years for injury to the person and for wrongful death.
  5. Code of Civil Procedure § 335.1California Legislature · California Code; verified Nov 12, 2026Two years for injury to or death of an individual caused by the wrongful act or neglect of another.
  6. Civil Practice Law and Rules § 214New York State Senate · Consolidated Laws of New York; verified Nov 12, 2026Three years for personal injury.
  7. Civil Practice Law and Rules § 214-cNew York State Senate · Consolidated Laws of New York; verified Nov 12, 2026Latent effects of exposure to a substance: three years computed from discovery of the injury.
  8. Civil Practice and Remedies Code § 16.003Texas Legislature · Texas Statutes; verified Nov 12, 2026Two years for personal injury and wrongful death.
  9. Civil Practice and Remedies Code § 16.012Texas Legislature · Texas Statutes; verified Nov 12, 2026Products liability actions within 15 years of sale, with an exception for certain latent diseases from exposure.

Accountability

Reviewed by

Craig Weiss, founder and managing attorney of CBW Law Firm

Craig Weiss

Managing Attorney · CBW Law

View full profile →

Attorney advertising. The content of this website may be considered attorney advertising under the rules of certain jurisdictions. The information on this website is for general information purposes only and should not be taken as legal advice for any individual case or situation. Viewing this site does not create an attorney-client relationship. Prior results do not guarantee a similar outcome. Statutes, regulations and case law change, and the law differs from state to state.