Beta Bionics Faces Class Action Over iLet Insulin Pump Disclosures
San Diego – September 10, 2026 -- Robbins LLP has filed a securities class action against Beta Bionics, Inc. (NASDAQ: BBNX) on behalf of investors who purchased common stock between July 30, 2025 and February 24, 2026, alleging the company misrepresented the safety and commercial viability of its iLet Bionic Pancreas insulin pump.
FDA warning letter contradicts prior company statements on device complaints
The complaint alleges that in October 2025, Beta Bionics disclosed an FDA Form 483 but told investors the issue was limited to complaint-reporting classification, not device safety, and that only minor customer complaints needed backfiling. Plaintiffs allege the FDA had in fact identified device malfunctions causing dangerously high insulin dosing and hypoglycemic events, with complaints numbering in the thousands and hundreds involving life-threatening incidents requiring medical intervention.