Facility

CONTEGO MEDICAL, INC

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

Key facts

2recalls · worst Class II

1inspections · 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)	3011471056
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	3801 Lake Boone Trail, Suite 100 Raleigh, NC, US 27607
Registration status	Active · expires 2026
Parent company	Contego Medical, INC (owner-operator 10050012)

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (2)

Temporary Carotid Catheter For Embolic Capture
Product code NTE (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250
Catheter, Angioplasty, Peripheral, Transluminal
Product code LIT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250

Recalls & enforcement

Class IIOngoing2026-06-29
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss…
Class IIOngoing2025-09-04
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.

FDA inspections (1)

NAI2024-08-21
No Action Indicated · Bioresearch Monitoring

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.

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. “CONTEGO MEDICAL, INC (FEI 3011471056) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011471056-contego-medical-inc/

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