VISIGLIDE2 G-260-3545SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170358258), received between Jun 11, 2020 and Jan 21, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Peeled/Delaminated

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, STENT PLACEMENT DURING THE PROCEDURE, GUIDEWIRE SHOWED PEELING OFF PHENOMENON. THE PEELED COATING MAY HAVE REMAINED IN THE PATIENT BODY. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24130435 ↗
• InjuryNov 20, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: VISIGLIDE 2 GUIDEWIRE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE DISTAL TIP CAME OFF THE GUIDEWIRE AND STAYED IN THE AMPULLA. BIOPSY FORCEPS WERE USED TO RETRIEVE THE TIP. THE TIP WAS REMOVED FROM THE PATIENT'S BODY. THERE WERE NO ADVERSE EFFECTS AND NO HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23606615 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. ON TUESDAY, (B)(6) 2025, DURING AN ERCP PROCEDURE, A VISIGLIDE 0.035 STRAIGHT GUIDEWIRE WAS USED. FROM THE BEGINNING, THE GUIDEWIRE WAS UNUSABLE DUE TO DAMAGE TO THE COATING. THE COATING APPEARED TO BE DEFECTIVE, WHICH CAUSED THE WIRE TO BECOME STUCK INSIDE THE EXTRACTION BALLOON. AS A RESULT, THE MEDICAL TEAM WAS FORCED TO USE A SECOND GUIDEWIRE FOR THE SAME PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED; HOWEVER, THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414352 ↗
• MalfunctionMay 24, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THEY HAD AN OUT OF BOX FAILURE, THE BLACK COATING WAS MISSING FROM A SECTION OF THE VISIGLIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392377 ↗
• MalfunctionApr 22, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT A SMALL SECTION OF THE G-240-3545S GUIDE WIRE INVOLVED WAS STRIPPED. THIS WAS FOUND WHILE LOADING IT IN THE TOME AND BEFORE USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187369 ↗
• InjuryDec 2, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE SINGLE USE GUIDEWIRE WAS USED DURING THE PROCEDURE. DURING PROCEDURE OF ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY PROCEDURE, INTRODUCTION OF THE GUIDE WIRE IN A DUODENOSCOPE, FROM THE FIRST MOBILIZATION OF THE WIRE, IT PEELED OFF IN THE PATIENT. THIS INCIDENT HAS NEVER HAPPENED BEFORE. THE PEELED OF PIECES OF THE WIRE REMAINED IN THE SMALL INTESTINE AND WILL BE EVACUATED BY NATURAL WAYS. CHANGE OF GUIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12915394 ↗
• MalfunctionJun 11, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED SINGLE USE GUIDEWIRE WAS USED DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS AN ERCP. AFTER USE, HYDROPHILIC COATING OF SUBJECT DEVICE WAS FOUND BROKEN OFF OUTSIDE THE PATIENT BODY. THE PHYSICIAN CHANGED TO ANOTHER DEVICE AND COMPLETED THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THE PROCESS WAS NOT DELAYED MORE THAN 15 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142144 ↗