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Evia HF-T
BIOTRONIK SE & Co. KG · Model 377208 · UDI-DI 04035479118372
NKE
Prescription
0
510(k) clearances
14,493
Adverse events (272 deaths)
28
Recalls
25
Facilities
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 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 |
| 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 telemetry or other no |
| 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 telemetry or other no |
| 2021-06-03 | Boston Scientific Corporation | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep |
| 2021-06-03 | Boston Scientific Corporation | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep |
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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.