SerosaFuse®Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450848135), received between Mar 12, 2026 and Sep 25, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

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.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Customer reported the combined transoral incisionless fundoplication TIF with concomitant hernia repair (cTIF) procedure was performed on 11AUG26 and discharged without sequelae. Patient reportedly returned ~3 days later (14AUG26) to the ER with melena where GI noted that one fastener site seemed to have been bleeding, but bleeding was seen to have stopped. Adult upper endoscope that was used at that time didn't retroflex fully so GI couldn't treat area with clips or any other means to ensure hemostasis. Patient was discharged. Patient presented again to the emergency room on (B)(6) 2026 with a hemoglobin of 6.2 and patient was given transfusion of blood and admitted. On (B)(6) 2026, the bleeding was noted to be stopped upon esophagogastroduodenoscopy (EGD) and the patient was discharged without additional intervention. The hemoglobin has returned to normal, and the patient is doing great.

  Patient problems: Melena

  MAUDE report 50896007 ↗
• InjurySep 9, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50698698 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  AN 81-YEAR-OLD MALE WITH A HISTORY OF A PRIOR ENDOSCOPIC-ONLY TIF PROCEDURE APPROXIMATELY 10 YEARS EARLIER UNDERWENT ROBOTIC HIATAL HERNIA REPAIR FOLLOWED BY AN ATTEMPTED CTIF PROCEDURE UNDER THE SAME ANESTHESIA. DURING ADVANCEMENT OF THE ESOPHYX DEVICE, SLIGHT RESISTANCE WAS ENCOUNTERED AT THE CRICOPHARYNGEUS BUT THE DEVICE WAS ADVANCED WITHOUT SIGNIFICANT FORCE. UPON ENDOSCOPIC INSPECTION, A LONGITUDINAL BLEEDING LACERATION OF THE ESOPHAGUS MEASURING APPROXIMATELY 18 CM (FROM 40 CM TO 22 CM) ABOVE THE GASTROESOPHAGEAL JUNCTION WAS OBSERVED. THE PHYSICIAN ATTRIBUTED THE MUCOSAL TEAR TO CONTACT WITH THE TIP OF THE ESOPHYX DEVICE. AN ADDITIONAL SMALL BLEEDING LACERATION WAS NOTED PROXIMAL TO THE CRICOPHARYNGEUS. THE TIF PROCEDURE WAS ABORTED. THE PATIENT WAS ADMITTED FOR OBSERVATION AND EVALUATION FOR POSSIBLE ESOPHAGEAL PERFORATION. FOLLOW-UP INDICATED THE PATIENT WAS DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Perforation

  MAUDE report 24586727 ↗