Warning Letter Cites a Number of Serious Violations
In a scathing warning letter, the FDA has cited Insightra Medical, Inc. for widespread regulatory violations involving its Intra-Aortic Balloon Pump (IABP) Catheter Kit—a device used in critical cardiovascular support. The agency flagged the device for being both adulterated and misbranded, highlighting significant risks to patient safety.
What Happened?
Insightra marketed its IABP Catheter Kit for use with pump consoles not cleared in its original 510(k)—specifically, the Cardiosave IABP Hybrid and the AutoCat 3. These systems were promoted as compatible on the company’s website and training materials without FDA approval, violating federal law. Any modification that alters a device’s intended use requires new clearance.
Unapproved Indications Still Being Marketed
Despite FDA’s 2013 reclassification of IABPs, which required Premarket Approval (PMA) for use in septic shock and pulsatile flow, Insightra continues to market these unapproved indications—a serious violation that’s been unaddressed for over a decade.
Device Malfunctions Not Reported
The FDA also found that Insightra failed to report serious adverse events:
- In one case, a ruptured balloon during use may have contributed to worsening heart failure in a patient, leading to urgent transplant listing.
- A second balloon rupture occurred months later. Despite clear reporting requirements, no MDRs were submitted to the FDA.
These are repeat violations from a 2015 inspection – raising concerns about the company’s long-standing noncompliance.
Quality System Failures
Insightra’s quality program showed multiple breakdowns:
- CAPA activities were poorly documented, incomplete, or ignored altogether—even when facing over 35 complaints about device leakage.
- Complaint handling was sloppy, with delayed investigations, missing reports, and inconsistent documentation.
- Design changes, such as a shelf life extension from 1 to 5 years, lacked appropriate validation or review.
Unreported Corrective Actions
The company updated its training to address catheter kinking—a known risk that could lead to gas embolism. But this correction was never reported to FDA, despite legal requirements to do so.
What’s Next?
The FDA demands that Insightra:
- Stop marketing unapproved uses
- Submit required 510(k) or PMA documentation
- Fix its MDR and quality systems
- Respond within 15 business days or face enforcement actions, including injunctions, product seizures, or civil penalties.
Why It Matters
This case underscores the FDA’s growing scrutiny of postmarket changes and quality lapses. For manufacturers of critical support devices like IABP catheters, regulatory diligence is not optional – it is essential for patient safety and market survival.
Insightra Acquired by Tennessee Medical Innovations, Owned by Mundomedis FZCO Dubai
According to its website, Insightra was funded by private equity investors Baird Capital and Tekla Capital Management who acquired a major stake in Insightra Medical Inc. In 2021 Insightra was acquired by Mundomedis FZCO Dubai, a privately held company with operations and investments in the medical device industry. In 2022, Insightra and its subsidiaries were acquired by Mundomedis subsidiary Tennessee Medical Innovations in February 2022.