Facility

ENDOTRONIX (Naperville)

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

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3024985933
Establishment type	Manufacture Medical Device
Location	1415 WEST DIEHL ROAD Suite 500 Naperville, IL, US 60563
Registration status	Active · expires 2026
Parent company	Endotronix (owner-operator 10055645)
Brand names	Cordella Pulmonary Artery Sensor System

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

System, Hemodynamic, Implantable
Product code MOM (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IITerminated2019-09-25
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

FDA inspections (2)

NAI2024-06-11
No Action Indicated · Bioresearch Monitoring
NAI2024-02-27
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Endotronix

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. “ENDOTRONIX (Naperville) (FEI 3024985933) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3024985933-endotronix-naperville/

Not open yet

Alerts for ENDOTRONIX (Naperville)

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.