Facility

BALT USA, LLC

6 recall(s) on record — most severe on record: Class I.

Key facts

6recalls · worst Class I

5inspections · worst VAI

—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)	3014162263
Establishment type	Manufacture Medical Device
Location	29 Parker Irvine, CA, US 92618
Registration status	Active · expires 2026
Parent company	Balt USA, LLC (owner-operator 10041614)
Brand names	Optima Coil System; XCEL Detachment Controller

Activity by year

Recalls (6)
Inspections (5)

Devices registered here (1)

Device, Neurovascular Embolization
Product code HCG (opens in a new tab) · Class II · Neurology · 21 CFR 882.5950

Recalls & enforcement

Class IOngoing2025-09-25
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Class IIOngoing2025-05-08
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class IIOngoing2024-01-03
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of …
Class IIOngoing2022-09-07
Product pouch label does not match up with carton label
Class IIOngoing2022-07-26
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Class IIOngoing2022-01-04
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure …

FDA inspections (5)

NAI2025-10-28
No Action Indicated · Postmarket Assurance: Devices
NAI2025-06-12
No Action Indicated · Bioresearch Monitoring
VAI2023-07-21
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2020-03-12
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-02-18
No Action Indicated · Compliance: 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 Balt USA, LLC

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. “BALT USA, LLC (FEI 3014162263) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014162263-balt-usa-llc/

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