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SJM MRI Activator™
ST. JUDE MEDICAL, INC. · Model EX4001 · UDI-DI 05414734510059
LWP
Prescription
0
510(k) clearances
157,487
Adverse events (1,862 deaths)
113
Recalls
35
Facilities
Description
Handheld Device
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 pacemakers (CRT-Ps)1 an |
| 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 state for the ACCO |
| 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 state for the ACCOLA |
| 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 state for the ACCO |
| 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 state for the ACCO |
| 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 state for the ACCO |
| 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 state for the ACCO |
| 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 state for the ACCO |
| 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 state for the ACCO |
| 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 state for the ACCO |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.