VISIGLIDE G-240-2527SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170282744), received between Dec 14, 2021 and Oct 30, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PART OF THE GUIDEWIRE BROKE OFF INTO THE PATIENT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE BROKEN WIRE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PROCEDURE AND ANESTHESIA WERE EXTENDED BY APPROXIMATELY 5 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566474 ↗
• InjuryJan 12, 2024Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT THE SINGLE USE GUIDEWIRE TIP BROKE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAM AND WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES BUT WAS NOT RECEIVED. THIS EVENT REQUIRES TWO REPORTS AS THE REPORTER WAS UNSURE WHICH DEVICE FAILED (TWO SEPARATE LOT NUMBERS). PATIENT IDENTIFIER (B)(6) IS FOR LOT 36K. PATIENT IDENTIFIER (B)(6) IS FOR LOT 33K. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504188 ↗
• InjuryJan 12, 2024Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT THE SINGLE USE GUIDEWIRE TIP BROKE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAM AND WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES BUT WAS NOT RECEIVED. THIS EVENT REQUIRES TWO REPORTS AS THE REPORTER WAS UNSURE WHICH DEVICE FAILED (TWO SEPARATE LOT NUMBERS). PATIENT IDENTIFIER (B)(6) IS FOR LOT 36K. PATIENT IDENTIFIER (B)(6) IS FOR LOT 33K. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504013 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ARTICLE WAS PUBLISHED IN AN AMERICAN SCHOLARLY JOURNAL (PLOSONE). IT WAS ABOUT A RETROSPECTIVE ANALYSIS OF A TOTAL OF 85 PATIENTS WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC ULTRASOUND (EUS) FOR SUSPECTED BILIARY STENOSIS AT THE (B)(6) MEDICAL CENTER IN (B)(6). IN THAT ARTICLE, IT WAS REPORTED THAT THERE WERE POST-PROCEDURE ACUTE PANCREATITIS AS ADVERSE EVENTS. SINCE VISIGLIDE WAS INCLUDED IN THE DEVICE USED, IT WAS TAKEN UP AS COMPLIMENTS BY OUR US SUBSIDIARY. HOWEVER, THERE WAS NO MENTION OF THE RELATIONSHIP BETWEEN ADVERSE EVENTS AND VISIGLIDE, AND THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE PATIENT WAS HARMED; IT WAS NOT SERIOUS INJURY.

  Patient problems: Pancreatitis

  MAUDE report 13001103 ↗