Thoraguard FGN-1387Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860000436427), received between Aug 9, 2025 and Aug 9, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Suction Failure” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2025Suction Failure; Suction Failure

  ACCORDING TO THE USER FACILITY'S REPORT (MDR MW5171897), ON (B)(6) 2025, A PATIENT UNDERWENT THORACIC SURGERY AND POSTOPERATIVELY HAD A CHEST TUBE CONNECTED TO A THORAGUARD DIGITAL CHEST DRAINAGE SYSTEM. ON POST-OPERATIVE DAY 1, A SCHEDULED MORNING CHEST X-RAY SHOWED A LARGE LEFT-SIDED PNEUMOTHORAX. THE PATIENT WAS ASYMPTOMATIC AND WELL-APPEARING AT THE TIME OF DISCOVERY. THE ATTENDING SURGEON DISCONNECTED THE CHEST TUBE FROM THE THORAGUARD SYSTEM AND CONNECTED IT TO AN ANALOG CHEST DRAIN, WHICH RELEASED AIR FROM THE LEFT SIDE. THROUGHOUT THE EXCHANGE, THE THORAGUARD DEVICE DID NOT DETECT AN AIR LEAK, AND AFTER REMOVAL FROM THE PATIENT'S CHEST TUBE, THE SYSTEM STILL DID NOT REGISTER AN AIR LEAK. THE PATIENT REMAINED ASYMPTOMATIC FOLLOWING THE INTERVENTION.

  Patient problems: Pneumothorax

  MAUDE report 22766654 ↗