HANAROSTENT® Esophagus TTS(CCC) ECBA-20-150-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08806367088598), received between Dec 16, 2022 and Nov 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryNov 12, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT WENT TO AN OUTSIDE FACILITY AND UNDERWENT CT IMAGING DUE TO ABDOMINAL PAIN, AND IT WAS REVEALED THAT A FRAGMENT OF THE STENT HAD BROKEN OFF AND MIGRATED INTO THE SMALL BOWEL, LIKELY CAUSING SMALL BOWEL OBSTRUCTION. PATIENT IS SCHEDULED FOR A DOUBLE-BALLOON ENTEROSTOMY TO RETRIEVE THE BROKEN STENT.

  Patient problems: Abdominal Pain; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 23531138 ↗
• InjuryJul 28, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THE ESOPHAGEAL HANAROSTENT WAS USED OFF LABEL AND PLACED IN THE PATIENT'S UPPER DUODENUM. IT WAS IN THE PATIENT FOR A PERIOD OF TIME AND THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND WENT TO THE EMERGENCY ROOM. IT WAS FOUND THROUGH A SCAN THAT THE DEVICE BECAME DISLODGED AND BROKE IN HALF. THE PATIENT WAS TAKEN FOR SURGERY TO REMOVE THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Abdominal Pain

  MAUDE report 17412986 ↗
• InjuryDec 16, 2022Entrapment of Device; Material Fragmentation

  THE CUSTOMER REPORTS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND REMOVAL OF AN ESOPHAGEAL HANAROSTENT (THAT HAD BEEN PLACED A MONTH PRIOR AT A DIFFERENT LOCATION), THE STENT BROKE APART DURING REMOVAL. THE PHYSICIAN WAS NOT ABLE TO REMOVE ALL OF THE STENT PIECES. THE PHYSICIAN WAS NOT CONCERNED BECAUSE THE CUSTOMER WAS SCHEDULED FOR ANOTHER UNSPECIFIED SURGERY NEXT WEEK. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15997593 ↗