Home › Device types › LWP
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA product code LWP · Class 3 · Unknown
229
Registered devices
156,364
Adverse events
113
Recalls
0
510(k) clearances
Devices with this code
Zenex MRI™ — ST. JUDE MEDICAL, INC.Adapta® — MEDTRONIC, INC.Sensia™ — MEDTRONIC, INC.Versa® — MEDTRONIC, INC.SJM MRI Activator™ — ST. JUDE MEDICAL, INC.ALTRUA™ 20 — BOSTON SCIENTIFIC CORPORATIONNA — MEDTRONIC, INC.ACCOLADE™ MRI DR — BOSTON SCIENTIFIC CORPORATIONAdapta™ — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Azure™ S SR MRI SureScan™ — MEDTRONIC, INC.Adapta™ S — MEDTRONIC, INC.ADVANTIO™ — BOSTON SCIENTIFIC CORPORATIONESSENTIO™ MRI SR — BOSTON SCIENTIFIC CORPORATIONAdapta™ — MEDTRONIC, INC.Entrant™ — ST. JUDE MEDICAL, INC.Advisa DR MRI™ SureScan® — MEDTRONIC, INC.EASYTRAK® 3 IS-1 — BOSTON SCIENTIFIC CORPORATIONAdapta™ — MEDTRONIC, INC.NA — MEDTRONIC, INC.Assurity MRI™ — ST. JUDE MEDICAL, INC.ACCOLADE™ MRI SR — BOSTON SCIENTIFIC CORPORATIONAdapta™ — MEDTRONIC, INC.
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 |
| 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 |
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