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Boston Scientific Pacemaker

Boston Scientific Pacemaker Recall Attorneys

Representing Injured Medical Device Users Nationwide

Have you experienced an injury as a result of a defective Boston Scientific pacemaker? Did you lose a loved one to an issue with their Boston Scientific pacemaker? Are you required to undergo surgery to replace or repair your Boston Scientific pacemaker? If so, you might have a defective medical device claim to bring against Boston Scientific, and Robert Peirce & Associates, P.C. can help.

For more than 40 years, our attorneys have been helping people and patients nationwide with injury claims and wrongful death lawsuits that involve defective medical devices. Some of our largest case results have been for medical-related cases, so you know that you can trust our experience and insight for a case as complicated as yours.

Call (844) 383-0565 now to speak with an attorney about your potential Boston Scientific pacemaker recall case. Initial consultations are always free, and we can help clients in any state with defective medical device cases.

Boston Scientific Pacemaker Recall

The U.S. Food and Drug Administration (FDA) issued a recall for several Boston Scientific pacemakers due to a severe defect that may cause the devices to permanently enter “Safety Mode.” Specifically, a battery cathode defect can cause the device to enter Safety Mode unexpectedly. While in this mode, the pacemaker does not follow a programmed therapy mode based on the patient’s cardiac health, making the device extremely unsafe and unreliable. This issue is believed to affect more than 10% of all such pacemaker devices manufactured before September 18.

There was a Class I Recall and Safety communication from the FDA issued on 3/3/2025, following an FDA Safety Communication on 12/16/2024. So far, the defect has been linked to more than 800 injuries and at least 2 fatalities.

Boston Scientific pacemakers affected by the FDA recall include:

  • ACCOLADE DR Pacemaker (Model Numbers L301, L311, L321, L331)
  • PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber pacemakers
  • VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)

The product names of the affected pacemakers are:

  • 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)

Models of the affected pacemakers are:

  • ACCOLADE DR Pacemaker, SL (Model Number L301)
  • SL MRI (Model Number L311)
  • EL (Model Number L321)
  • EL MRI (Model Number L331)

Dangers of the Defective Pacemakers

The FDA has warned that some of the worst potential dangers of the defective Boston Scientific pacemakers include:

  • Abnormally slow heartbeats (bradycardia)
  • Fainting episodes (syncope)
  • Need for emergency surgery for device replacement
  • Cardiac complications
  • Death

Due to the severity of the risks that can be caused by the pacemaker defects, anyone with a Boston Scientific or Accolade pacemaker is urged to contact their healthcare providers for more information about how to address the issue. Anyone with a potentially defective pacemaker who has experienced unusual cardiac events or complications should seek emergency medical attention.

Can You Bring a Lawsuit Against Boston Scientific?

Across the country, patients are already planning legal action against Boston Scientific for selling an unsafe medical device. Strict product liability laws may be able to hold the manufacturer liable for any device failures linked to a defect, regardless of the exact reasons why a failure occurred.

You might be able to start an injury claim against Boston Scientific if:

  • You were injured due to a defect affecting your Boston Scientific pacemaker;
  • You have been advised to undergo surgery to remove or repair your Boston Scientific pacemaker; or,
  • You lost a loved one due to heart complications related to a recalled Boston Scientific pacemaker.

If you think you could have a valid lawsuit against Boston Scientific, you should start by collecting a copy of your medical records. Our attorneys’ work can benefit from medical records that detail the type of Boston Scientific pacemaker device you have and when it was surgically implanted, as well as what heart-related medical conditions you have been diagnosed with. Don’t worry if you aren’t sure where to get your medical records because we can help you with this step of your case, as well as all others.

Call Us Now – (844) 383-0565

Don’t wait to contact our Boston Scientific pacemaker recall attorneys, serving clients nationwide with defective medical device claims. We are always ready to deliver reliable legal representation from a firm that combines large law office power with the compassion that you would expect from a smaller, local law office. Our whole team is here to help you make sense of your situation and help you through it.

Dial (844) 383-0565 and speak with a member of our team today during a free case evaluation.

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