Home › Device types › NKE
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA product code NKE · Class 3 · Unknown
63
Registered devices
14,493
Adverse events
28
Recalls
0
510(k) clearances
Devices with this code
NA — MEDTRONIC, INC.Edora 8 HF-T QP — BIOTRONIK SE & Co. KGConsulta® CRT-P — MEDTRONIC, INC.Solara™ Quad CRT-P MRI SureScan™ — MEDTRONIC, INC.Entrant™ — ST. JUDE MEDICAL, INC.Viva™ CRT-P — MEDTRONIC, INC.Merlin™ — ST. JUDE MEDICAL, INC.Evia HF — BIOTRONIK SE & Co. KGVALITUDE™ X4 CRT-P — BOSTON SCIENTIFIC CORPORATIONMerlin@home™ — ST. JUDE MEDICAL, INC.Serena™ CRT-P MRI SureScan™ — MEDTRONIC, INC.Anthem® — ST. JUDE MEDICAL, INC.VISIONIST™ CRT-P — BOSTON SCIENTIFIC CORPORATIONEpyra 8 HF-T — BIOTRONIK SE & Co. KGEluna 8 HF-T — BIOTRONIK SE & Co. KGSolara™ CRT-P MRI SureScan™ — MEDTRONIC, INC.Merlin.net — CARDIOMEMS, INC.INTUA™ — BOSTON SCIENTIFIC CORPORATIONNeutrino™ — ST. JUDE MEDICAL, INC.Frontier™ — ST. JUDE MEDICAL, INC.QUADRA ALLURE MP™ — ST. JUDE MEDICAL, INC.Merlin.net — ST. JUDE MEDICAL, INC.Etrinsa 8 HF-T — BIOTRONIK SE & Co. KGAmvia Sky HF-T QP — BIOTRONIK SE & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Boston Scientific Corporation | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pac |
| 2025-08-20 | Boston Scientific Corporation | 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 |
| 2025-08-20 | Boston Scientific Corporation | 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 |
| 2025-08-20 | Boston Scientific Corporation | 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 |
| 2025-08-20 | Boston Scientific Corporation | 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 |
| 2025-08-20 | Boston Scientific Corporation | 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 |
| 2024-12-12 | Boston Scientific Corporation | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during t |
| 2024-12-12 | Boston Scientific Corporation | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during t |
| 2021-06-03 | Boston Scientific Corporation | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior t |
| 2021-06-03 | Boston Scientific Corporation | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior t |
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