Boston Scientific Corporation — Class I: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P
The FDA has designated a Class I recall involving a software maintenance release (SMR6) for Boston Scientific VALITUDE and VISIONIST CRT-P EL devices. The advisory population has been expanded to include all CRT-P and dual-chamber extended life (DR-EL) devices within the ACCOLADE family.
Boston Scientific Corporation, healthcare providers utilizing VALITUDE and VISIONIST CRT-P EL models, and regulatory/QA departments overseeing cardiac rhythm management portfolios.
A Class I designation is the most serious recall category, indicating that the software issue could potentially cause serious health consequences. The expansion of the advisory population to include additional device models suggests that the software vulnerability or maintenance requirement is more systemic across the product family than previously identified. Regulatory teams may need to assess the effectiveness of current software deployment protocols for implanted devices.
Regulatory and QA teams should ensure that the Brady software maintenance release 6 (SMR6) is deployed to the expanded advisory population and document the update within the Quality Management System. Clinical teams should identify patients with affected CRT-P and DR-EL models to facilitate necessary software maintenance.
Class I. 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. 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.. Firm: Boston Scientific Corporation (Saint Paul MN United States). Status: Ongoing.
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