HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) DNJF-22-120-230Recalls & reported problems
M.I.Tech Co., Ltd. · Un-covered self-expanding nitinol Duodenum stent · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08806367076762), received between Nov 18, 2022 and Nov 18, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
Device problems
- Difficult or Delayed Positioning1
- Fracture1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2022Difficult or Delayed Positioning; Fracture
THE CUSTOMER REPORTS FOLLOWING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT REMOVAL PROCEDURE (FOR THE INDICATION OF FRACTURED DUODENAL STENT) USING A HANAROSTENT DUO UNCOVERED 22 DM 12CM STENT, THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO BLEEDING. A COMPUTERIZED TOMOGRAPHY (CT) WAS COMPLETED, AND IT SHOWED THAT THE STENT HAD FRACTURED AND WAS POSSIBLY THE CAUSE OF THE BLEEDING. ANATOMICAL CHALLENGES THAT COULD HAVE CONTRIBUTED TO THE DEVICE BREAKING: DIFFICULT ANGLE OF ANATOMICAL POSITION WHERE STENT WAS DEPLOYED. INTERVENTIONS REQUIRED AS A RESULT OF THIS EVENT INCLUDE CT, X-RAY, ADMIT TO HOSPITAL, EGD, REMOVAL OF BROKEN STENT IN STOMACH. THE OUTCOME/RESULT OF THE FOLLOW-UP EGD PERFORMED THE NEXT DAY: REMOVED APPROXIMATELY 3CM OF THE PROXIMAL STENT, REMAINDER OF STENT LEFT IN PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS: PATIENT LEFT HOSPITAL AND PLACED ON HOSPICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15827935 ↗
Other Stent, Metallic, Expandable, Duodenal devices
- Evolution G48026Cook Ireland Ltd · STENT,METALLIC,EXPANDABLE,DUODENAL1 death57 reports
- WallFlex™ Duodenal M00565020Boston Scientific Corporation · STENT,METALLIC,EXPANDABLE,DUODENAL42 reports
- WallFlex™ Duodenal M00565030Boston Scientific Corporation · STENT,METALLIC,EXPANDABLE,DUODENAL2 deaths38 reports
- WallFlex™ Duodenal M00565010Boston Scientific Corporation · STENT,METALLIC,EXPANDABLE,DUODENAL1 death30 reports
- Evolution G48027Cook Ireland Ltd · STENT,METALLIC,EXPANDABLE,DUODENAL30 reports
- Evolution G48025Cook Ireland Ltd · STENT,METALLIC,EXPANDABLE,DUODENAL14 reports
- WallFlex™ Duodenal M00555860Boston Scientific Corporation · Stent, metallic, expandable, duodenal2 reports
- WallFlex™ Duodenal M00555870Boston Scientific Corporation · Stent, metallic, expandable, duodenal1 death2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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