MicroVention Costa Rica S.R.L.

Warning LetterClosed

Charlie Noel SVP, International Operations-CR MicroVention Costa Rica S.R.L. Coyol Free Zone, B 33 Zona Franca Coyol, Edificio B33 El Coyol De Alajuela , Alajuela 20101 Costa RicaFEI 3010079067Issued Sep 30, 2022Center for Devices and Radiological Health

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Violations6

Issue DateSep 30, 2022

Product TypeMedical Devices

StatusClosed

Closeout LetterNov 17, 2025

Letter Details

Firm: MicroVention Costa Rica S.R.L.
Location: Charlie Noel SVP, International Operations-CR MicroVention Costa Rica S.R.L. Coyol Free Zone, B 33 Zona Franca Coyol, Edificio B33 El Coyol De Alajuela , Alajuela 20101 Costa Rica
FEI Number: 3010079067
Country: United States
Issue Date: September 30, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: November 17, 2025

Summary

MicroVention Costa Rica S.R.L. was cited for manufacturing medical devices (Headway Microcatheter, LVIS, LVIS Jr, Scepter C and XC Occlusion Balloon Catheter, SOFIA Catheters, and BOBBY Balloon Guide Catheter) in violation of current good manufacturing practice requirements under 21 CFR Part 820. The primary violation identified was failure to properly validate manufacturing processes that cannot be fully verified by subsequent inspection and testing, including inadequate documentation of validation activities, approval signatures, and major equipment validated. The FDA conducted an inspection of the Costa Rica facility from May 23-26, 2022, and the company submitted responses to the inspectional observations between June and August 2022, but compliance gaps remained unresolved.

MicroVention Costa Rica S.R.L. FDA Warning Letter, September 30, 2022