Solar GI LGI H20, Trolley system G3-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717775955047), received between Jan 5, 2026 and Mar 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.

   Z-2669-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Decrease in Pressure

  CUSTOMER RETURNED GI PUMP FOR REPAIR AS IT WAS REPORTED THE DEVICE WAS FAULTY.

  Patient problems: Convulsion/Seizure

  MAUDE report 24720437 ↗
• MalfunctionJan 6, 2026Decrease in Pressure

  THE PUMP FAILED, RESULTING IN NEGATIVE PRESSURE READINGS.

  Patient problems: Convulsion/Seizure

  MAUDE report 23975313 ↗
• MalfunctionJan 5, 2026Decrease in Pressure

  THE PUMP WAS FAULTY RESULTING IN NEGATIVE PRESSURE READINGS.

  Patient problems: Convulsion/Seizure

  MAUDE report 23967719 ↗