Recall Z-0101-2026 ยท NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Boston Scientific Corporation
Model Number U125, VALITUDE CRT-P EL
| Date | Oct 10, 2025 (initiated Aug 20, 2025) |
| Status | Open, Classified |
| Reason | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). |
| Root cause | Other |
| Action | Boston Scientific issued an "Urgent Medical Device Correction" notice to its customers on 08/18/2025 via letter. The notice provides an update to the December 2024 customer communication regarding the potential for the ACCOLADE family of pacemakers to initiate Safety Mode due to a high battery impedance state and contains recommendations timely upgrade of pacemaker software to prevent the occurrence of Safety Mode in an ambulatory setting. On 09/05/2025 an update to the 08/18/2025 notice (via letter), superseding the prior notice to address two unintended behaviors associated with the Model 3 |
| Quantity | 3620 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.