Device recall
Z-1771-2026: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1771-2026 |
|---|---|
| Recall event | 98615 |
| 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. |
| Product code | NKE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P030005 |
| FEI number | 2124215 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database