Accolade Pacemaker: Accolade, Proponent, Essentio, Altrua, Visionist, and Valitude Pacemaker Recall

Yesterday on December 16, 2024, FDA issued a Safety Communication concerning a Boston Scientific Accolade pacemaker recall. The Boston Scientific company identified a group of pacemakers with an increased potential to enter “Safety Mode” during telemetry or other normal, higher-power operations due to a batter issue.

The issue regarding this Boston Scientific Accolade recall causes limited functionality, which in turn, “has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients.”

Like us, FDA issued this communication to raise awareness of the Accolade recall notice. FDA is conducting an ongoing evaluation with Boston Scientific concerning the Boston Scientific Accolade. We expect to see additional information and possible risk mitigation measures to follow. The Accolade pacemaker is a family of Boston Scientific pacemakers.

What Accolade Pacemakers are Subject to the Boston Scientific Recall?

The FDA Safety Communication about the pacemaker recall concerns the Accolade pacemakers. They are medical devices. These Accolade devices “are a family of pacemakers and cardiac resynchronization therapy pacemakers” that surgeons implant in patients “to treat abnormal heartbeat (arrhythmia) and moderate to severe heart failure.” The particular Accolade pacemakers at issue are:

• ACCOLADE™;
• PROPONENT™;
• ESSENTIO™;
• and ALTRUA™ 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and
• VISIONIST™; and
• VALITUDE™ cardiac resynchronization therapy pacemakers (CRT-Ps)

Boston Scientific notes in its Urgent Medical Device Information piece more specifically that this concerns “A subset of approximately 13% of devices from the ACCOLADE family1, built before Sep 2018….”

Note: the picture here is not the actual device. We did not want to mess around with potential copyright issues, so we asked ChatGPT to create an image. 

What Is the Problem with the Accolade Pacemakers Subject to the Accolade Pacemaker Recall?

The Accolade recall concerns a very specific issue. A manufacturing issue with the cathode of some of the Accolade pacemaker batteries may lead to underpowering the device. That may cause it to go into Safety Mode. This mode offers limited functioning. It may not properly regulate the heart’s functioning, which is what the patient is relying on the Accolade device to do. Thus, it requires replacement.

Fundamentally, it appears the company detected this and their employees’ practice and techniques found a higher concentration of lithium salts. “There have been two (2) reported deaths in pacemaker dependent patients implanted with devices from the advisory population that initiated Safety Mode in an ambulatory setting.”

What Product Liability Claims May Arise from the Boston Scientific Pacemaker Recall?

Assuming there is a valid claim, negligence is always something to consider when there is a recall. Other, more traditional product liability claims are also on the differential. Could be a failure to warn design defect depending on additional information concerning the Accolade recall.

The notice states the battery underpowering the pacemaker system is due to a manufacturing issue. Thus, a manufacturing defect claim may be possible. It is likely this is a PMA/Class III device. Thus, the legal doctrine, preemption may come into play. We have seen mixed results with manufacturing defect claims in medical device preemption cases, but this one is far more clear than those prior cases.

Why are you wishy-washy about the regulatory status?

The Accolade pacemaker is a family of medical devices. There are several Accolade and related devices. One of the earliest regulatory submissions we found was from 2014 concerning the ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (PACEMAKER DEVICES). It harkens back to a PMA from the late 1990s. We found dozens of supplements and hundreds of submissions. There are no Accolade heart implant 510(k) submissions in FDA’s 510(k) database. Thus, it’s complicated and we do not want to commit to anything at this time on an information website.

What Should Patients and Healthcare Providers Do About the Boston Scientific Accolade Pacemaker Recall?

Straight from the FDA Safety Communication concerning the Accolade recall, the guidance given is as follows:

I. “Recommendations for Patients and Caregivers

• Continue to work with your health care provider to monitor your Accolade pacemaker device, either remotely or during your existing in-office follow-up schedule.
  • Discuss with your health care provider if you are a candidate for remote monitoring. Remote monitoring enables your provider to receive regular updates, including a Safety Mode alert, from your device.
  • If not a candidate for remote monitoring, discuss an in-office monitoring schedule with your health care provider to help ensure that your device is functioning properly.
  • If monitoring indicates that your device entered Safety Mode, discuss a plan with your health care provider for surgery to replace the pacemaker.
• Discuss your current pacing needs and potential risk of your device entering Safety Mode with your health care provider.
  • If you are determined to be at high risk of harm  if your device entered Safety Mode based on your pacing needs, your health care provider may contact you about replacement of your device.
• Consult with your health care provider if you have new or worsening symptoms such as lightheadedness or loss of consciousness, or questions about your device potentially entering Safety Mode.
• Report any problems with your Accolade pacemaker device to the FDA.

[II.] Recommendations for Health Care Providers

• Review the recall notice from Boston Scientific for a subset of Accolade pacemaker devices with an increased risk to permanently enter Safety Mode due to the battery underpowering the system because of a manufacturing issue with the battery cathode. The recall notice includes the following important information:
  • Description of the battery problem and clinical impact of Safety Mode,
  • Recommended actions for individual patient evaluation, device replacement, and follow-up intervals, and
  • Model numbers and Unique Device Identifier (UDI) information.
• Be aware that the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices.
  • Consider the potential need for early device replacement and a patient’s specific reliance on their pacemaker when making treatment recommendations.
  • Discuss the benefit and risks of all available treatment options with your patients.
  • Remain alert for further updates and recommendations from the FDA and the manufacturer.
  • While the FDA’s evaluation is ongoing, health care providers should:
    • Monitor patients with Accolade pacemaker devices through remote or in-office visits for red box alerts indicating that a patient’s device is in Safety Mode, or symptoms indicating device performance issues, such as lightheadedness or loss of consciousness. General prophylactic device replacement is not recommended.
    • If monitoring indicates that the device has entered Safety Mode, schedule surgery for a replacement pacemaker. Timely replacement is recommended to avoid risks associated with time spent in Safety Mode.
• Report any problems your patients experience with Accolade pacemaker devices to the FDA.”

https://www.fda.gov/medical-devices/safety-communications/accolade-pacemaker-devices-boston-scientific-and-potential-need-early-device-replacement-fda-safety?utm_medium=email&utm_source=govdelivery

This is not the First Boston Scientific Pacemaker Recall

There have been other Accolade pacemaker recalls. For example, there was one in 2018, a Class 2 device recall of the Accolade pacemaker. In a letter sent with that one, the company explained, “Boston Scientific has identified a subset of approximately 2,900 active ACCOLADE”, PROPONENT”, and ESSENTIO” pacemakers and VISIONIST” and VALITUDE” cardiac resynchronization therapy pacemakers (CRT-Ps) with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.” That model came to market via a PMA the company submitted in 2015.

Here is a chart we compiled (do not rely on this as it is informational; review FDA’s materials directly, links provided).

Accolade Pacemaker Recalls

Boston Scientific’s Accolade family of pacemakers has undergone several regulatory evaluations and recalls since its introduction. Below is a summary of its regulatory history:

KBA is Here to Help Patients and Families the Accolade Pacemaker May Have Injured

It may be too soon to tell if there are valid claims related to this particular Boston Scientific Accolade pacemaker recall. Getting the information out is a great first step. We have eyes on this and will investigate further.

Anyone with ACCOLADE™, PROPONENT™, ESSENTIO™, and ALTRUA™ 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST™ and VALITUDE™ cardiac resynchronization therapy pacemakers impacted by this Accolade is welcome to contact us. We can obtain medical records and investigation potential claims for you. 855-KBA-LAWS (522-5297).