FDA 483 - Invisian Medical, LLC. - March 31, 2025

Invisian Medical, LLC. in Prairie Village, KS, was cited for inadequate design validation of its Minne Ties Agile MMF Suture System during an FDA inspection. The firm failed to ensure the device conformed to user needs regarding effective cutting device removal and the introducer needle's ability to pass through the clasp channel. This resulted in unresolved design issues and subsequent patient complaints.