Boston Scientific recalls specific CRT-P pacemakers with outdated software. Updated software (SMR6) is available to prevent potential risks in heart conditions. Affected devices include VALITUDE and VISIONIST models with certain model numbers.
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Boston Scientific is recalling specific cardiac pacemakers (VALITUDE and VISIONIST CRT-P EL models) because outdated software could pose risks for patients with certain heart conditions. This recall requires updating the software to prevent potential complications.
The outdated software may not properly handle certain heart conditions, potentially leading to ineffective treatment. This could cause issues like irregular heart rhythms or reduced cardiac output in patients with conduction disorders or pacemaker syndrome.
Patients with specific heart conditions who own the recalled pacemakers, including those with conduction disorders, pacemaker syndrome, or low cardiac output. The most at-risk individuals are those with dual-chamber pacemakers.
Check if your pacemaker is labeled as VALITUDE CRT-P EL (Model U125), VALITUDE CRT-P EL MRI (Model U128), VISIONIST CRT-P EL (Model U225 or U226), or VISIONIST CRT-P EL MRI (Model U228). Use the device lookup tool at www.BostonScientific.com/lookup to confirm if your specific model is affected.
Visit www.BostonScientific.com/lookup and enter your model or serial number to see if your device is affected.
The outdated software may not properly handle certain heart conditions, potentially causing ineffective treatment for patients with conduction disorders, pacemaker syndrome, or low cardiac output.
If your device is not in the advisory population, no action is required. Check the device lookup tool at www.BostonScientific.com/lookup to confirm.
The recall does not require immediate action for safety, but updating the software ensures the device functions properly for your specific heart condition.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1771-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1771-2026 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.
