Sauder Schelkopf is investigating potential claims on behalf of patients implanted with certain Boston Scientific pacemakers following a serious FDA recall linked to dangerous battery failures.
NYT March 19, 2026: She Died After Her Pacemaker Battery Failed. Its Maker Knew of Problems for Years.
What Happened?
The U.S. Food and Drug Administration (FDA) has classified Boston Scientific’s recall of its ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE pacemakers as a Class I recall—the most serious type, reserved for products that may cause serious injury or death.
According to the FDA, a manufacturing defect in the device battery may cause the pacemaker to unexpectedly enter “Safety Mode,” a condition that:
- Cannot be reversed
- May significantly reduce device functionality
- Can result in interruption of pacing, leading to serious complications or death
Once in Safety Mode, patients may require urgent surgery to remove and replace the device.
Reported Injuries and Deaths
The FDA has reported:
- 832 injuries
- At least 2 deaths associated with the defect
Additional reporting suggests the scope of the issue may be broader. Investigations have found that battery failures and safety issues may have persisted for years, with internal testing showing unusually high failure rates in some devices.
What Are the Risks?
Affected patients may experience:
- Lightheadedness or dizziness
- Fainting (syncope)
- Irregular or slow heart rhythms (bradycardia)
- Loss of consciousness
- Sudden cardiac complications
In some cases, these failures can occur without warning, particularly during higher-power device functions such as remote monitoring or data transmission.
Which Devices Are Affected?
- Product Names:
- ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers
- VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)
- Model:
- ACCOLADE DR Pacemaker, SL (Model Number L301)
- SL MRI (Model Number L311)
- EL (Model Number L321)
- EL MRI (Model Number L331)
- Unique Device Identifier (UDI)/Lot/Serial Numbers:
(A full list of affected models appears in the FDA recall notice.)
Contact Sauder Schelkopf
If you or a loved one has been implanted with a Boston Scientific pacemaker and experienced complications, device failure, or required early replacement surgery, you may have legal rights.
Experience Matters
Sauder Schelkopf has a nationally recognized litigation practice. The firm currently serves as court-appointed lead counsel in courts across the country. The attorneys at Sauder Schelkopf have recovered over $1 billion on behalf of their clients and class members. Our firm was recognized by the Legal Intelligencer’s 2022 Professional Excellence Awards. The Legal Intelligencer’s Professional Excellence Awards honor Pennsylvania law firms and attorneys who have made a significant, positive impact on the legal profession. Our firm was named in the Litigation Departments of the Year (Specialty Area category; runner-up), an award that honors the best litigation practice in a small or mid-sized firm in Pennsylvania. This recognition was based on the firm’s 2021 litigation work and its important ongoing cases. LawDragon has recognized our attorneys in its list of the “500 Leading Plaintiff Consumer Lawyers” for 2022. This list notes: “From the opioid epidemic to toxic substances and defective products, truck accidents to wildfires and sexual abuse, these are the lawyers who stand on the front line in individual lawsuits and class actions seeking justice.” Mr. Schelkopf was named to Pennsylvania’s Best Lawyers® 2022 for Class Actions/Mass Tort Litigation. The American Lawyer named Mr. Sauder to its 2021 Northeast Trailblazers. The honor recognizes 60 lawyers who are “truly agents of change.” It “recognizes professionals in the Northeast who have moved the needle in the legal industry.” The Legal Intelligencer named Mr. Sauder and Mr. Schelkopf in its 2020 Pennsylvania Trailblazers list recognizing 31 lawyers who “have taken extra measures to contribute to positive outcomes . . . and who are truly agents of change.” The Legal highlighted the firm’s innovative work on advocacy as class counsel in large institutional sex abuse cover-ups, women’s, and children’s rights. Our attorneys have also consistently been recognized by their peers being named to Pennsylvania SuperLawyer, a distinction held by the top 5% of attorneys in Pennsylvania. The National Trial Lawyers Association has also selected our attorneys as the Top 100 Trial Lawyers in Pennsylvania.
We Want to Hear from You
If you or a loved one has been implanted with a Boston Scientific pacemaker and experienced complications, device failure, or required early replacement surgery, you can contact the attorneys at Sauder Schelkopf by filling out the form on this page.