Boston Scientific lawsuits and recalls span active shareholder litigation, two Class I device recalls tied to deaths and thousands of injuries, a newly consolidated multidistrict case over spinal cord stimulators, and older resolved matters including a Guidant criminal plea and a nearly $188.7 million transvaginal mesh settlement.
Shareholder Securities Fraud Lawsuit (2026)
In April 2026, shareholders sued Boston Scientific and five senior executives in Troike v. Boston Scientific Corporation, No. 26-cv-40075, in the U.S. District Court for the District of Massachusetts.1Newsfilecorp. BSX Investor Deadline The complaint covers a class period of July 23, 2025 through February 3, 2026, and alleges the company inflated its stock price by withholding that growth in its U.S. Electrophysiology segment was unsustainable, downplaying competitive pressure, and making misleading positive statements on earnings calls.2MD+DI Online. Shareholders Suing Boston Scientific Over Electrophysiology Claims
On February 4, 2026, Boston Scientific reported fourth-quarter earnings of $0.45 per share, below its own $0.48 to $0.52 guidance, with Electrophysiology missing Wall Street consensus by $33 million. The stock fell more than 17%.1Newsfilecorp. BSX Investor Deadline The lead plaintiff deadline was May 4, 2026, and no class has been certified.3Rosen Legal. Boston Scientific Corporation
Active Class I Device Recalls
Class I is the FDA’s most serious recall category, used when a device may cause serious injury or death. Boston Scientific has two active Class I recalls in 2025 and 2026.
AXIOS Stent
The FDA classified the recall of the AXIOS Stent and Electrocautery-Enhanced Delivery System as Class I on February 25, 2026, after reports of problems with stent deployment and expansion during delivery. As of December 23, 2025, Boston Scientific reported 167 serious injuries and three deaths.4U.S. Food and Drug Administration. Stent Recall: Boston Scientific Removes Certain AXIOS Stents
Boston Scientific said the three deaths occurred when the device was used “outside of its indication or in an investigational manner,” and involved a “cascade of events with special circumstances” including palliative care decisions and altered anatomy.5MedPage Today. FDA Issues Early Safety Alert for Boston Scientific AXIOS Stent6MedTech Dive. Boston Scientific AXIOS Stent Recall The company told customers in December 2025 to stop using and distributing affected products. Patients with successfully implanted AXIOS stents do not need additional intervention, because the deployment issues occur only during initial delivery.4U.S. Food and Drug Administration. Stent Recall: Boston Scientific Removes Certain AXIOS Stents
Accolade Pacemakers
The FDA also classified a correction to the ACCOLADE family of pacemakers and cardiac resynchronization therapy pacemakers as a Class I recall. A software update meant to address high battery impedance instead introduced new problems, including unintended activation of “Safety Mode.” As of March 18, 2026, Boston Scientific reported four deaths and 2,557 serious injuries.7U.S. Food and Drug Administration. Pacemaker Correction: Boston Scientific Issues Correction for Accolade Pacemakers and CRT-Ps
The battery impedance issue was first identified in December 2024. An August 2025 firmware update was intended to fix it but caused additional problems; a further update in March 2026 was released to resolve those and expand the correction to all affected models, including the Essentio, Proponent, Accolade, Altrua 2, Valitude, and Visionist lines.8MD+DI Online. Boston Scientific Accolade Pacemaker Recall: 4 Deaths, 2,557 Injuries Reported
Spinal Cord Stimulator MDL
Boston Scientific faces growing litigation over its WaveWriter Alpha spinal cord stimulator. A February 2026 Mississippi lawsuit alleged that lead wires migrated out of position, causing the device to stop functioning and requiring full surgical removal. The complaint claimed the company promoted the system as offering “superior pain relief” without independent premarket clinical testing for substantial modifications.9AboutLawsuits.com. Boston Scientific SCS Lawsuit Filed Over Problems With WaveWriter Alpha System
On June 5, 2026, the U.S. Judicial Panel on Multidistrict Litigation consolidated 23 pending cases into MDL No. 3181 before Judge Josephine L. Staton in the Central District of California. The cases allege device failures involving leads, batteries, charging, and power delivery, along with unnecessary shocks, burns, and erratic stimulation.10U.S. Judicial Panel on Multidistrict Litigation. In Re: Boston Scientific Corporation Spinal Cord Stimulator Products Liability Litigation Transfer Order
Prior $38.5 Million Securities Settlement
A separate securities case, In re Boston Scientific Corporation Securities Litigation, Case No. 1:20-cv-12225-ADB, resolved for $38.5 million and covered stock purchased between September 16 and November 16, 2020. Final judgment was entered on April 23, 2024, and claims administration closed on February 7, 2025.11Boston Scientific Securities Litigation. In Re Boston Scientific Corporation Securities Litigation An initial payout to qualifying claimants went out on April 10, 2025, and a second on February 10, 2026, with further rolling distributions. The filing deadline has passed and no new claims are being accepted.12Boston Scientific Securities Litigation. FAQ
Transvaginal Mesh Settlement
Boston Scientific was a defendant in In Re Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326), managed in the Southern District of West Virginia and formally closed on February 11, 2021.13U.S. District Court, Southern District of West Virginia. In Re Boston Scientific Corp., Pelvic Repair System Products Liability Litigation In March 2021, the company agreed to a nearly $188.7 million multistate settlement with 47 states and the District of Columbia, resolving allegations that it misrepresented and failed to disclose risks including chronic pain, infections, and voiding dysfunction. The agreement required plain-language disclosure of complications, improved training, and registration of company-sponsored clinical studies on ClinicalTrials.gov. Boston Scientific no longer markets transvaginal mesh for pelvic organ prolapse but continues to sell similar devices for stress urinary incontinence.14Washington State Attorney General. AG Ferguson: Mesh Manufacturer Boston Scientific Will Pay More Than $8.8 Million
Claims administration is closed. No new mesh claims are being accepted.15WA AG Mesh Settlement. Washington State Attorney General Mesh Settlement
Guidant Criminal Plea and Civil Settlement
Boston Scientific acquired cardiac device maker Guidant in 2006. Federal prosecutors said Guidant knew as early as 2002 that its Ventak Prizm 2 defibrillator had a life-threatening defect, and discovered similar problems with its Contak Renewal 1 and 2 in 2003, yet continued selling remaining stock and concealed the issues from the FDA, doctors, and patients.16U.S. Department of Justice. United States Files Suit Against Guidant and Boston Scientific
In February 2010, Guidant pleaded guilty to two misdemeanor counts under the Federal Food, Drug, and Cosmetic Act: submitting false and misleading reports to the FDA about the Prizm 2, and failing to notify regulators within ten days about a safety correction to the Renewal models. A federal judge in Minnesota accepted the plea on January 12, 2011, imposing three years of probation and compliance reviews including unannounced inspections.17MPR News. Guidant Plea Deal The combined criminal fine and forfeiture totaled approximately $296 million.18Justia Contracts. Boston Scientific – Guidant Plea Agreement
In 2013, Boston Scientific and its Guidant subsidiaries paid $30 million to settle civil False Claims Act allegations that Guidant knowingly sold defective devices implanted in Medicare patients between 2002 and 2005. The case originated with a whistleblower suit brought by a patient who received one of the defective devices.19HHS Office of Inspector General. Boston Scientific and Subsidiaries to Pay $30 Million