FDA WARNING_LETTER - Insightra Medical Inc. - January 27, 2025

On June 3, 2025, the FDA issued a Warning Letter to Insightra Medical Inc. following an inspection from January 21-27, 2025, at their Clarksville, TN facility. The inspection revealed significant violations regarding their Double Pump and Ultra Intra Aortic Balloon Pump (IABP) Catheter Kits.

Key violations include: 1. **Unapproved Device Violations:** The IABP Catheter Kit is adulterated and misbranded. Insightra Medical Inc. marketed the device as compatible with Cardiosave IABP Hybrid and AutoCat 3 without submitting a new premarket notification (510(k)), a significant change to its intended use (21 CFR 807.81(a)(3)(ii)). Additionally, the firm continues to market the IABP Catheter Kit for "septic shock" and "pulsatile flow generation" indications without an approved Premarket Approval (PMA) or Product Development Protocol (PDP), as required by a December 2013 reclassification order and a March 2014 FDA letter. This renders the device adulterated under 21 U.S.C. § 351(f)(1)(A).

2. **Medical Device Reporting (MDR) Violations:** * Failure to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17). The