Recall Z-1771-2026— Boston Scientific Corporation

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2026-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 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.. Reason: 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.

Recalling firm

Boston Scientific Corporation

Classification

Class I

Status

Ongoing

Initiated

2026-03-19

Firm location

Saint Paul, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.