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Boston Scientific VALITUDE & VISIONIST CRT-P Recall

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Mode

Updated March 19, 2026

Boston Scientific has recalled several models of its VALITUDE and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps) because updated software (Brady SMR6) is now available and the devices may not be performing optimally without it. These are implanted heart devices, making timely action critical.

Is the Boston Scientific Corporation recalled? Yes. This product was recalled by FDA on March 19, 2026. Details below.

What is recalled

Boston Scientific Cardiac Resynchronization Therapy Pacemakers (CRT-Ps), specifically: 1. VALITUDE CRT-P EL, Model Number U125 2. VALITUDE CRT-P EL MRI, Model Number U128 3. VISIONIST CRT-P EL, Model Number U225 4. VISIONIST CRT-P EL, Model Number U226 5. VISIONIST CRT-P EL MRI, Model Number U228

Am I affected

You may be affected if you have an implanted Boston Scientific CRT-P pacemaker with one of these model numbers: U125, U128, U225, U226, or U228. Check your device ID card or ask your cardiologist or device clinic which model you have.

What to do right now

Contact your cardiologist or cardiac device clinic as soon as possible to ask about receiving the Brady software maintenance release 6 (SMR6) update for your device. Do not stop using your pacemaker, it is a life-sustaining implant. No consumer contact number was provided; reach out directly to your healthcare provider or the facility that manages your device.

The hazard

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

Brands affected

Boston Scientific Corporation
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1771-2026
Classification
Class I
Recalled
March 19, 2026
Read the official notice

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