Federal cases over Boston Scientific spinal cord stimulators are coordinated as MDL No. 3181 in California.
These implants send electrical pulses to reduce chronic pain; FDA actions and filings are undisputed facts, while defect and warning claims remain unproven allegations. The cases affect patients with implanted Boston Scientific systems who report loss of relief or repeat surgery. Readers can use the split below to track the docket, check FDA notices, and discuss medical questions with their own doctor.
Table of Contents
- What the court has established
- What federal regulators confirm
- What plaintiffs allege
- What is not decided and what to do
What the court has established
On June 5, 2026, the Judicial Panel on Multidistrict Litigation centralized the federal cases as MDL No. 3181. The cases sit in the Central District of California before Judge Josephine L.
Staton for coordinated discovery and pretrial proceedings, according to the transfer order. On Sept. 1, 2026, the Panel listed 29 pending MDL 3181 actions. That count shows an early and growing docket, not a final case set, according to the Panel statistics report.
What federal regulators confirm
FDA said Boston Scientific asked customers to remove all unused Infinion CX leads from stock. The agency states body stress at the anchor site may cause high impedance or fracture, inadequate stimulation, and explant or replacement, according to the FDA MedWatch bulletin. For that lead issue, Boston Scientific reported 1,081 serious injuries and no deaths as of May 27, 2026.
FDA identifies it as its most-serious recall type. A separate entry in FDA's recall database covers WaveWriter Alpha 16/32 implantable-pulse-generator kits. The generator may reset while charging and briefly interrupt pain therapy, and the recall was initiated July 17, 2024.
What plaintiffs allege
On Oct. 23, 2026, plaintiffs filed a Master Personal Injury Complaint covering Precision, Precision Spectra, Precision Montage, and WaveWriter systems. It alleges defective manufacture, failure to warn doctors and patients, and overstated durable relief, according to AboutLawsuits court coverage.
A second consolidated complaint pursues a different track against FDA over its original clearance of the devices. That Administrative Procedure Act theory is contested, and no court has ruled on it. These filings outline what plaintiffs seek to prove. They do not establish that any device was defective, any warning was inadequate, or any patient injury was caused.
What is not decided and what to do
No liability finding, settlement, or bellwether trial date exists. Motions to dismiss were due Nov.
20, 2026, so defect and warning claims remain allegations at the pretrial stage. Patients should not stop or change stimulation therapy on their own. Device response varies, and explant decisions carry surgical risks that require direct medical review.
- Keep the implant card, surgery date, and system name together
- Note loss of relief, new pain, charging problems, or repeat procedures
- Bring FDA notices to the implanting physician and ask about checks or imaging
- Ask about risks and options before agreeing to revision or removal
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