Home › Device types › QFV
Implantable Pulse Generator
FDA product code QFV · Class 3 · Unknown
11
Registered devices
135
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
OPTIMIZER® — Impulse Dynamics (usa) Inc.OPTIMIZER — Impulse Dynamics (usa) Inc.OPTIMIZER — Impulse Dynamics (usa) Inc.Vesta — Impulse Dynamics (usa) Inc.Vesta — Impulse Dynamics (usa) Inc.Intelio — Impulse Dynamics (usa) Inc.OPTIMIZER™ — Impulse Dynamics (usa) Inc.OPTIMIZER® — Impulse Dynamics (usa) Inc.Guardio — Impulse Dynamics (usa) Inc.OPTIMIZER™ — Impulse Dynamics (usa) Inc.OMNI™ II — Impulse Dynamics (usa) Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-05 | IMPULSE DYNAMICS (USA) INC | OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure sympt |
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