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Impulse Dynamics (usa) Inc.

Last updated May 24, 2026

Information

Device	Model / Reference	Registries	Class	Status
Optimizer	Smart Mini	FDA UDI	Class III	Active
Optimizer	Lite	FDA UDI	Class III	Active
Optimizer™	Mini Charger System	FDA UDI	Class III	Active
Omni™ Ii	Programmer System (with OMNI Smart Software)	FDA UDI	Class III	Active
Optimizer™	CCM X10	FDA UDI	Class III	Active
Intelio	Intelio Portable Programmer Unit	FDA UDI	Class III	Active
Optimizer®	CCM X10	FDA UDI	Class III	Active
Vesta	Vesta Charger System (For OPTIMIZER Lite)	FDA UDI	Class III	Active
Optimizer®	Mini Charger System	FDA UDI	Class III	Active
Guardio	Guardio Charger System	FDA UDI	Class III	Active
Vesta	Vesta Charger System	FDA UDI	Class III	Active
OPTIMIZER SMART Mini IPG	P180036	FDA PMA	Class III	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 5, 2024	Z-1173-2024	—	open, classified	OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.