Boston Scientific recalls specific pacemaker models with updated software maintenance release 6 (SMR6) for improved safety. Affected devices include ACCOLADE and ESSENTIO series pacemakers with certain model numbers and use-by dates.
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
Boston Scientific is recalling specific pacemaker models that require an updated software maintenance release (SMR6) to address potential safety issues. This recall affects patients with certain types of pacemakers, including those with dual-chamber capabilities for heart rhythm disorders.
The recall involves updated software maintenance release 6 (SMR6) for specific pacemaker models. This update addresses potential safety issues related to dual-chamber modes used for treating heart rhythm disorders, but the hazard is not described as causing immediate harm in normal use.
Patients with the listed pacemaker models, particularly those with dual-chamber capabilities for treating conduction disorders, VVI intolerance, or low cardiac output. The risk is low as the update addresses software maintenance without immediate danger.
Check if your pacemaker model number is listed in the provided models (e.g., ESSENTIO SR SL L100, ACCOLADE DR SL L301). Devices with a use-by date (UBD) on or before June 30, 2025, are also affected. Use the device lookup tool at www.BostonScientific.com/lookup to confirm.
Review your pacemaker model number to see if it matches the listed models (e.g., ESSENTIO SR SL L100, ACCOLADE DR SL L301).
Enter your model or serial number into the device lookup tool at www.BostonScientific.com/lookup to confirm if your device is affected.
No, the recall requires a software update, not immediate discontinuation of use.
Affected models include ESSENTIO SR SL (L100), ESSENTIO DR SL (L101), ACCOLADE SR SL (L300), and others listed in the recall notice.
Only specific models with dual-chamber capabilities and certain use-by dates are affected; check the model number or use the lookup tool.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1770-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1770-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
