If you or a family member was implanted with a Boston Scientific defibrillator, pacemaker, or defibrillation lead that later failed or was recalled, you may have grounds for a Boston Scientific defibrillator lawsuit. The company and its Guidant subsidiary have already paid close to $972 million in combined settlements, criminal fines, and civil penalties over defective cardiac devices, and law firms are now taking claims tied to three newer recalls: the EMBLEM S-ICD subcutaneous electrode, the ENDOTAK RELIANCE defibrillation leads, and the ACCOLADE family of pacemakers.1DAIC. Boston Scientific to Pay $296 Million Settlement for Guidant FDA Violations
Which Boston Scientific Devices Are Driving Current Lawsuits
EMBLEM S-ICD Subcutaneous Electrode (Model 3501)
The EMBLEM S-ICD is a defibrillator that sits under the skin rather than threading wires into the heart. In December 2020, Boston Scientific warned physicians that the Model 3501 electrode could fracture just below the proximal sensing ring, a weakness traced to a notch created during assembly. A fractured electrode may fail to deliver a life-saving shock during cardiac arrest.2PMC. EMBLEM S-ICD Lead Fracture Analysis
The FDA issued a Class I recall in February 2021 covering 19,919 devices manufactured between March 2016 and November 2020. At that point, 27 fracture reports had produced 26 serious injuries and one death.3DAIC. Boston Scientific Recalls Emblem S-ICD After 26 Serious Injuries and One Death The recall was formally terminated on July 23, 2024, but lawsuits over injuries linked to the electrode are still being filed.4FDA. EMBLEM S-ICD Recall Record
ENDOTAK RELIANCE Defibrillation Leads
This is the largest of the current recalls. In July 2025, Boston Scientific sent safety notifications for ENDOTAK RELIANCE 4-SITE and 4-FRONT defibrillation leads manufactured between 2002 and 2021. Roughly 354,000 affected leads remain implanted in patients worldwide.5Boston Scientific. ePTFE ICD Lead Calcification Physician Letter
The problem is a nonstick expanded polytetrafluoroethylene (ePTFE) coating on the shock coils. Calcium deposits build up on the coating over time, raising electrical resistance until the lead can no longer deliver a full corrective shock. The FDA classified the issue as a Class I recall and, as of the July 2025 notification, reported 386 serious injuries and 16 deaths.6Fierce Biotech. FDA Updates Serious Recall Alert for Boston Scientific Implanted Defibrillator Leads
Attorneys have flagged a four-year gap between Boston Scientific’s 2021 decision to stop manufacturing the ePTFE-coated leads and its 2025 safety communications, arguing it supports a failure-to-warn theory. No consolidated multidistrict litigation had been formally established as of early 2026.7Foster James LLC. Endotak Reliance Lead Lawsuit
ACCOLADE Pacemakers and CRT-P Devices
A manufacturing defect in ACCOLADE pacemakers and cardiac resynchronization therapy devices can cause an unanticipated buildup of lithium salts in the battery. That drives up battery impedance and can push the device into “Safety Mode,” a fixed backup pacing state that cannot be reprogrammed.8Boston Scientific. Accolade Safety Mode Physician Letter For pacemaker-dependent patients, Safety Mode has been linked to fainting, cardiac pauses, worsening heart failure, and at least two deaths.
The FDA upgraded the ACCOLADE recall to Class I in February 2025, covering roughly 203,000 devices made before September 2018. By March 2026, the FDA reported 2,557 serious injuries and four deaths tied to the defect.9FDA. Pacemaker Correction: Boston Scientific Issues Correction for Accolade Pacemakers and CRT-Ps
Boston Scientific has reportedly offered some affected patients around $2,500 toward the cost of replacement surgery. Attorneys investigating the recall have urged patients not to sign anything without legal review, since individual product liability claims may be worth substantially more. Multiple firms were pursuing individual claims involving device failure, unplanned surgeries, and adverse cardiac events as of late 2025; no class action had been publicly announced.10Fob James Law Firm. Boston Scientific Pacemaker Lawsuit
Who Can File a Claim
Eligibility depends on the device and the injury, but the general pattern is consistent across these recalls. Patients who suffered cardiac arrest, device failure, inappropriate shocks, unplanned replacement surgery, or other serious cardiac events linked to a covered Boston Scientific device may bring a product liability claim. Families of patients who died can bring wrongful death actions.
Two points worth knowing before you assume you’re excluded. First, for the EMBLEM S-ICD, some firms are taking cases from patients who experienced device failure even where their specific unit was not formally part of the Class I recall list.11Foster James LLC. Boston Scientific Lawsuit Second, filing deadlines vary by state, but a common rule is two years from the date the patient discovered the injury. That means a device implanted years ago can still be actionable if the failure or the connection to the recall is recent.
One boundary: these are individual product liability and wrongful death claims. Except for the older Guidant matters, no consolidated MDL or class action for the EMBLEM S-ICD, ENDOTAK RELIANCE, or ACCOLADE recalls had been announced as of early 2026, so patients are filing on their own behalf rather than joining a certified class.
What Boston Scientific Has Already Paid
The company’s litigation history matters because it shows what these cases have been worth before. Almost all of that history traces to Guidant Corporation, which Boston Scientific acquired in 2006 along with its liabilities.
Guidant manufactured the Ventak Prizm 2 DR, Contak Renewal, and Contak Renewal 2 defibrillators. A design flaw could cause the devices to short-circuit at the moment they were supposed to deliver a shock. Guidant learned about the Prizm 2 problem in April 2002 and about the Renewal defects by November 2003 but did not tell doctors, patients, or the FDA for years.12U.S. Department of Justice. Boston Scientific and Subsidiaries Pay $30 Million for Guidant’s Sale of Defective Heart Devices The concealment came out only after 21-year-old Joshua Oukrop died on March 14, 2005, when his Prizm 2 short-circuited. Guidant issued a physician advisory on May 23, 2005, after learning the New York Times was about to publish.13The New York Times. Maker of Heart Device Kept Flaw From Doctors
By January 2006, Guidant had recalled or issued safety advisories on about 88,000 defibrillators and more than 200,000 pacemakers, with at least seven deaths linked to the devices at that point.14NBC News. Boston Scientific to Buy Guidant for $27.2 Billion What followed for patients and the government:
- A $240 million product liability settlement in November 2007 covering 8,550 patient claims, consolidated as In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, MDL No. 05-1708, in the District of Minnesota. Plaintiffs alleged that the defendants had “knowingly sold them inherently defective defibrillator devices with potential life-threatening defects over a period of three years.”15Fierce Healthcare. Plaintiffs Obtain $240 Million Amended Settlement in Guidant Defibrillators Products
- A criminal guilty plea by Guidant LLC in February 2010 to two misdemeanor counts under the Federal Food, Drug, and Cosmetic Act, with total penalties above $296 million ($253.9 million fine plus $42 million in criminal forfeiture). The FDA called it the largest criminal penalty ever imposed on a device manufacturer under the Act.16Justia. Guidant LLC Plea Agreement17Reuters. Boston Scientific Unit Pleads Guilty in DOJ Case
- A $30 million False Claims Act settlement in October 2013 over sales of the defective devices to Medicare patients, with whistleblower James Allen receiving $2.25 million of that recovery.12U.S. Department of Justice. Boston Scientific and Subsidiaries Pay $30 Million for Guidant’s Sale of Defective Heart Devices
Combined with related costs, Boston Scientific’s cumulative payouts on the Guidant defibrillators reached roughly $972 million. The defective devices were linked to at least 13 deaths.1DAIC. Boston Scientific to Pay $296 Million Settlement for Guidant FDA Violations
What to Do If You Have a Recalled Device
Start with your cardiologist. For the ENDOTAK RELIANCE leads, Boston Scientific has asked physicians to monitor low-voltage shock impedance and to consider replacement when a 28-day average exceeds 150 ohms, a threshold associated with about a 1 in 10 risk of shock failure. Programming shocks to maximum energy and switching to initial polarity can reduce risk in the interim.5Boston Scientific. ePTFE ICD Lead Calcification Physician Letter For the ACCOLADE pacemakers, Boston Scientific has released a software update meant to catch the high-impedance condition before the device enters Safety Mode, though an earlier version of that fix introduced problems of its own and had to be corrected.8Boston Scientific. Accolade Safety Mode Physician Letter
Replacement is not automatically the safer choice. Boston Scientific itself has acknowledged that long-implanted, calcified leads carry increased extraction risks, and for many patients the medical judgment weighs the danger of a flawed device against the danger of surgery to remove it.
On the legal side, keep your device model and serial number, your implantation and any explant records, records of any shocks or failures, and any correspondence you receive from Boston Scientific or your physician about the recall. If Boston Scientific offers a payment toward replacement surgery, have a product liability attorney review the terms before you sign. Because state statutes of limitations often run from discovery of the injury rather than implantation, waiting on a consultation can matter more than patients expect.