Facility

Impulse Dynamics USA Inc

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012563838
Establishment type	Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	50 Lake Center Executive Parkway Marlton, NJ, US 08053
Registration status	Active · expires 2026
Parent company	Impulse Dynamics USA Inc (owner-operator 10032587)
Brand names	OPTIMIZER Smart System; OPTIMIZER Smart Mini System

Activity by year

Recalls (1)

Devices registered here (1)

Implantable Pulse Generator
Product code QFV (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2024-01-05
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.

All facilities operated by Impulse Dynamics USA Inc

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Impulse Dynamics USA Inc (FEI 3012563838) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012563838-impulse-dynamics-usa-inc/

Not open yet

Alerts for Impulse Dynamics USA Inc

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.