Boston Scientific Accolade pacemakers recalled after Safety Mode failures tied to 2,557 injuries and 4 deaths. Free, no-obligation case review.
Start Your Free Case Review →Boston Scientific is facing growing legal scrutiny after the U.S. Food and Drug Administration (FDA) classified its May 2026 recall of Accolade-family pacemakers as a Class I recall — the agency’s most serious designation, reserved for products that may cause serious injury or death. If you or a loved one were implanted with one of the recalled devices and experienced a malfunction, a Boston Scientific Accolade pacemaker recall lawsuit may allow you to recover compensation for medical expenses, lost income, and pain and suffering. No attorney-client relationship is formed by reading this page.
On May 7, 2026, the FDA announced a Class I recall covering Boston Scientific’s full Accolade family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) — including the Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude models. The recall stems from a battery defect that can cause an affected device to permanently enter “Safety Mode,” a restricted operating state that limits the pacemaker’s ability to properly regulate a patient’s heartbeat. According to the FDA, the issue has been linked to 2,557 serious injuries and 4 deaths as of the recall date.
This is not Boston Scientific’s first action involving these devices. In December 2024, the company issued an initial recall covering a narrower subset of Accolade-family devices manufactured before September 2018, which the FDA upgraded to Class I status in February 2025 after tying it to 832 injuries and two deaths. The May 2026 recall expands that earlier action to the entire Accolade product line and addresses the defect through a mandatory software correction rather than device removal. Boston Scientific had already released a software update in September 2025 — months before the broader recall — which plaintiffs’ attorneys argue shows the company knew about the Safety Mode risk well before warning patients and physicians.
Unlike many device recalls, this action does not require physical removal of the pacemaker. Instead, Boston Scientific is directing physicians to update affected devices and flag each patient’s medical record. Patients who have not yet had this update performed remain at risk of their device unexpectedly entering Safety Mode.
You may have a claim if you or a family member were implanted with one of the recalled Accolade-family devices — Accolade, Proponent, Essentio, Altrua 2, Visionist, or Valitude — and experienced any of the following:
You do not need to have already had your device replaced to speak with an attorney, and you do not need to know your exact model number before reaching out — our team can help confirm whether your device is part of the recalled population.
Patients and families affected by the Accolade recall may be entitled to compensation for medical expenses related to monitoring, reprogramming, or replacement surgery; lost wages and reduced earning capacity; pain and suffering; and, in cases involving a death linked to device failure, wrongful death damages. Cases like this have resulted in significant recoveries for clients harmed by defective medical devices, though no specific outcome or dollar amount can be guaranteed in advance. Carey & Danis LLC handles these cases on a contingency-fee basis — there is no fee unless we win your case.
⚠ Time-Sensitive: Deadlines Apply
Statutes of limitations vary by state and case type. If you believe you have a claim, do not wait — contact Carey & Danis LLC today for a free, no-obligation case evaluation. There is no fee unless we win.
Most product liability claims must be filed within two to three years of when the injury was — or reasonably should have been — discovered, but the exact deadline depends on the state where you live and where the injury occurred. Because this matter involves both a 2025 recall and a broader 2026 recall, the relevant filing window may differ depending on when your device first malfunctioned.
It is an FDA Class I recall, announced May 7, 2026, covering Boston Scientific’s Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude pacemakers and CRT-Ps. A battery defect can cause these devices to permanently enter Safety Mode, restricting their ability to properly regulate a patient’s heartbeat. The FDA has linked the issue to 2,557 serious injuries and 4 deaths.
Safety Mode is a restricted operating state that limits a pacemaker to basic, unipolar pacing and sensing instead of the therapy programmed specifically for your heart condition. For a patient who depends on consistent pacing, this can mean inadequate treatment and a real risk of fainting, severe fatigue, or a dangerously slow heartbeat.
The recalled models are the Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude pacemakers and CRT-Ps. Your cardiologist or electrophysiologist’s office can confirm your exact model and serial number, or you can contact us and we can help you find out.
Possibly. If your device entered Safety Mode, malfunctioned, or required replacement before the software correction was performed, you may still have a claim for the injuries, surgery, or other harm that already occurred, even if the device has since been corrected or replaced.
Not necessarily. Many claims in recalls like this one involve patients who already underwent replacement surgery. Filing deadlines vary by state, so it’s important to speak with an attorney as soon as possible to find out how much time you have left to act.
Family members of a patient who died after a recalled pacemaker malfunctioned or entered Safety Mode may be able to pursue a wrongful death claim against Boston Scientific. An attorney can review the medical records and circumstances of your loved one’s care to evaluate your options at no cost.
Carey & Danis LLC is a national plaintiffs’ law firm with decades of experience holding manufacturers accountable for defective and dangerous medical devices. Our attorneys are actively investigating claims on behalf of patients and families affected by the Accolade pacemaker recall, and we work on a contingency-fee basis so you pay nothing unless we recover compensation on your behalf.
This page is for informational purposes only and does not constitute legal advice. Submitting an inquiry does not create an attorney-client relationship. For more on this recall, see the FDA’s medical device recall database.
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