FDA WARNING_LETTER - Pensar Medical LLC - April 28, 2026

On August 21, 2026, the FDA issued a warning letter to Lion Street Medical, doing business as Pensar Medical LLC, following an inspection of its Houston, Texas facility from April 14 to April 28, 2026. The inspection focused on the company’s Negative Pressure Wound Therapy (NPWT) systems, including the WoundPro and MicroDoc product lines. The FDA concluded that these medical devices are misbranded and adulterated under the Federal Food, Drug, and Cosmetic Act due to significant regulatory non-compliance.

The main violations include failures in Medical Device Reporting (MDR), where the firm failed to establish adequate procedures for identifying and reporting events involving serious injury. Specifically, the company failed to report a case where a patient sustained a wound infection necessitating medical intervention. Additionally, the firm did not notify the FDA regarding a software correction for the MicroDoc system intended to reduce health risks. Further issues involve Quality Management System violations, such as failing to document risk management across product lines, implementing software design changes without proper verification or validation, and maintaining an ineffective Corrective and Preventive Action (CAPA) program with numerous incomplete records.

The FDA determined that the company"s previous responses were inadequate as they did not demonstrate completed corrective actions. Lion Street Medical is required to submit a written response within 15 business days outlining a comprehensive plan to address these systemic failures, including a timetable for implementation. Failure to take prompt action may result in regulatory consequences such as product seizures, legal injunctions, or financial penalties.