Boston Scientific Corporation Recall: Boston Scientific Cardiac Resynchronization Therapy
Boston Scientific Corporation Recall: Boston Scientific Cardiac Resynchronization Therapy is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125
| Recalling firm | Boston Scientific Corporation |
|---|---|
| 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 for recall | 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 fa |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | worldwide |
| Recall initiated | 20260319 |
| Recall number | Z-1771-2026 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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