Boston Scientific pacemakers recalled again—software update now available
The U.S. Food and Drug Administration (FDA) has announced a new recall related to ongoing safety concerns with several Boston Scientific pacemakers.
The issue, first announced in 2024, involved certain pacemakers permanently entering into safety mode. When this happens, the devices are unable to properly regulate the heart, making them much less effective. Over time, the issue was associated with more than 800 patient injuries and two deaths.
Now, however, a new software update—Brady SMR6—has been completed that can address this risk going forward. Brady SMR6 was also developed to correct two “unintended behaviors” associated with Boston Scientific’s previous software update for these devices.
Unlike many recalls, no devices need to be returned to the manufacturer due to this ongoing issue. However, this is still a Class I recall, which means the FDA believes there is a risk of these pacemakers causing a serious injury or death if the software update is not installed as recommended.
Devices included in this recall
More than 1.4 million devices are included in this latest Class I recall. This includes pacemakers, cardiac resynchronization therapy pacemakers and dual-chamber extended life pacemakers.
According to the FDA, the full list of impacted devices includes:
- ESSENTIO SR SL, Model Number L100;
- ESSENTIO DR SL Pacemaker, Model Number L101;
- ESSENTIO SR SL MRI Pacemaker, Model Number L110;
- ESSENTIO DR SL MRI Pacemaker, Model Number L111;
- ESSENTIO DR EL Pacemaker, Model Number L121;
- ESSENTIO DR EL MRI Pacemaker, Model Number L131;
- PROPONENT SR SL Pacemaker, Model Number L200;
- PROPONENT DR SL Pacemaker, Model Number L201;
- PROPONENT DR (VDD) SL Pacemaker, Model Number L209;
- PROPONENT SR SL Pacemaker, Model Number L210;
- PROPONENT DR SL MRI Pacemaker, Model Number L211;
- PROPONENT DR EL Pacemaker, Model Number L221;
- PROPONENT DR EL MRI Pacemaker, Model Number L231*;
- ACCOLADE SR SL Pacemaker, Model Number L300;
- ACCOLADE DR SL Pacemaker, Model Number L301;
- ACCOLADE SR SL MRI Pacemaker, Model Number L310;
- ACCOLADE DR SL MRI Pacemaker, Model Number L311;
- ACCOLADE DR EL Pacemaker, Model Number L321;
- ACCOLADE DR EL MRI Pacemaker, Model Number L331*;
- ALTRUA 2 SR SL Pacemaker, Model Number S701;
- ALTRUA 2 DR SL Pacemaker, Model Number S702;
- ALTRUA 2 DR EL Pacemaker, Model Number S722.
- VALITUDE CRT-P EL, Model Number U125;
- VALITUDE CRT-P EL MRI, Model Number U128;
- VISIONIST CRT-P EL, Model Number U225;
- VISIONIST CRT-P EL, Model Number U226;
- VISIONIST CRT-P EL MRI, Model Number U228.
In March, Boston Scientific sent out an Urgent Medical Device Correction that included specific instructions on the timing of any necessary updates. Many patients may be able to wait until their next scheduled follow-up appointment with no further actions necessary.
The company also emphasized that certain devices may need to be replaced earlier than originally anticipated. On the other hand, replacing a device early before confirming it is necessary “is not recommended.”
“Patient safety remains Boston Scientific’s highest priority, and we are committed to communicating with physicians and healthcare professionals to ensure timely, relevant information for managing your patients,” the company said in an Urgent Medical Device Correction to its customers.
More information from the FDA is available here and here.
Boston Scientific shares its perspective
Boston Scientific shared a statement with Cardiovascular Business about this latest update to a story that has been ongoing since late 2024.
"The March 2026 advisory communication announced availability of the SMR6 software, which prevents the device from going into safety mode in an ambulatory setting due to a battery issue described in the advisory," the company said. "The advisory communication provides physicians with details about affected devices, how to upgrade devices with the new software, as well as recommendations for patient care."
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.