Facility

INSIGHTRA MEDICAL, INC.

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

Key facts

1recalls · worst Class II

2inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	3003945344
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	2543 Madison St Clarksville, TN, US 37043
Registration status	Active · expires 2026
Parent company	INSIGHTRA MEDICAL, INC. (owner-operator 9054804)
Brand names	Insightra Balloon Inflation Device

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Syringe, Balloon Inflation, Exempt
Product code PTM (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1650

Recalls & enforcement

Class IITerminated2025-07-19
Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.

FDA inspections (2)

OAI2025-01-27
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2018-06-19
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

FDA warning letters (1)

Warning Letter2025-06-03
Warning Letter (opens in a new tab) · Clarksville Tennessee

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by INSIGHTRA MEDICAL, 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. “INSIGHTRA MEDICAL, INC. (FEI 3003945344) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003945344-insightra-medical-inc/

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