VISIGLIDE G-240-2545SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170282782), received between Jan 7, 2019 and Nov 25, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT PART OF THE GUIDE WIRE USED HAD BEEN STRIPPED, PREVENTING THE DEVICE FROM BEING FITTED DURING THE WORK. THE EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771564 ↗
• MalfunctionNov 25, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE GUIDE WIRE PEELED OFF EVEN THOUGH IT HAS NOT BEEN INTRODUCED INTO THE ENDOSCOPE OPERATING CHANNEL. ANOTHER GUIDE WIRE WAS TAKEN BEFORE STARTING THE PROCEDURE. THE EVENT OCCURRED PRE-TREATMENT AND THERE WAS NO PATIENT INVOLVED. THERE WAS NO PATIENT INJURY NOTIFIED BY THE CUSTOMER. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771553 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE: BEYOND CHOLECYSTITIS.". LITERATURE SUMMARY: ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) IS AN ALTERNATIVE TO SURGERY FOR ACUTE CHOLECYSTITIS (AC) IN POOR OPERATIVE CANDIDATES. HOWEVER, THE ROLE OF EUS-GBD IN NON-CHOLECYSTITIS (NC) INDICATIONS HAS NOT BEEN WELL STUDIED. WE COMPARED THE CLINICAL OUTCOMES OF EUS-GBD FOR AC AND NC INDICATIONS. CONSECUTIVE PATIENTS UNDERGOING EUS-GBD FOR ALL INDICATIONS AT A SINGLE CENTER WERE RETROSPECTIVELY ANALYZED. FIFTY-ONE PATIENTS UNDERWENT EUS-GBD DURING THE STUDY PERIOD. THIRTY-NINE (76%) PATIENTS HAD AC WHILE 12 (24%) HAD NC INDICATIONS. NC INDICATIONS INCLUDED MALIGNANT BILIARY OBSTRUCTION (N = 8), SYMPTOMATIC CHOLELITHIASIS (N = 1), GALLSTONE PANCREATITIS (N = 1), CHOLEDOCHOLITHIASIS (N = 1), AND MIRIZZI¿S SYNDROME (N = 1). TECHNICAL SUCCESS WAS NOTED IN 92% (36/39) FOR AC AND 92% (11/12) FOR NC (P > 0.99). THE CLINICAL SUCCESS RATE WAS 94% AND 100%, RESPECTIVELY (P > 0.99). THERE WERE FOUR ADVERSE EVENTS IN THE AC GROUP AND 3 IN THE NC GROUP (P = 0.33). PROCEDURE DURATION (MEDIAN 43 VS. 45 MIN, P = 0.37), POST-PROCEDURE LENG

  Patient problems: Abdominal Pain; Fistula; Hemorrhage/Blood Loss/Bleeding; Pneumoperitoneum; Respiratory Failure

  MAUDE report 17556570 ↗
• InjuryJul 2, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE SINGLE USE GUIDEWIRE WAS USED DURING THE ERCP PROCEDURE. THE TIP OF A DISPOSABLE GUIDEWIRE (G-240-2545S) BROKE OFF. THE BROKEN TIP WAS HEADED FOR THE COMMON BILE DUCT, THE PHYSICIAN RETRIEVED IT FROM THE PATIENT'S BODY. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106230 ↗
• MalfunctionMay 12, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT PRE-TREATMENT, WHEN THE CUSTOMER LOOKED AT A SET OF SINGLE USE GUIDEWIRE, THEY FOUND THAT THE COATING WAS DAMAGED ABOUT 5CM. THEY DID NOT USE THE WIRE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811039 ↗
• MalfunctionMar 23, 2021Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED SINGLE USE GUIDEWIRE WAS USED DURING THE ERCP PROCEDURE. WHILE PERFORMING CANNULA INSERTION, THE VISIGLIDE BROKE. THE PROCEDURE WAS COMPLETED WITH SIMILAR EQUIPMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11549526 ↗
• MalfunctionMar 22, 2021Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED SINGLE USE GUIDEWIRE WAS USED DURING THE ERCP PROCEDURE. WHILE PERFORMING CANNULA INSERTION, THE VISIGLIDE BROKE. THE PROCEDURE WAS COMPLETED WITH SIMILAR EQUIPMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11538612 ↗
• MalfunctionJun 11, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE WIRE BROKE DURING STENT DEPLOYMENT. ERCP GUIDEWIRE, STRAIGHT TIP.

  Patient problems: No Information

  MAUDE report 10143490 ↗
• MalfunctionApr 21, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING THE PROCEDURE, THE ERCP GUIDEWIRE, STRAIGHT TIP -CORE OF THE GUIDEWIRE CAME THROUGH THE HYDROPHILIC COATING. IT WAS CONFIRMED THAT THE COATING DID NOT FALL OFF THE GUIDEWIRE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED. ASHITAKA RECEIVED IMAGES ON 01APR2020; VISUAL INSPECTION OF THE IMAGES DEEMED THE EVENT REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9981109 ↗
• InjuryJan 7, 2019Break; Break

  THE USER FACILITY REPORTED THAT DURING THE VERY FIRST CASE, THE SINGLE USE GUIDEWIRE HAD "BROKE" NEAR THE 10CM MARK WHEN HE WAS PERFORMING AN ERCP CASE. THE DISTAL PART OF THE BROKEN WIRE BECAME STUCK IN THE CBD; HOWEVER, WITH THE GREAT EFFORTS OF THE DOCTOR HE WAS ABLE TO REMOVE THE BROKEN PIECE OF THE WIRE FROM THE CBD. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED. THE PIECE OF THE WIRE THAT HAD DISLODGED IN THE PATIENT WAS RETRIEVED WITH THE USE OF A SNARE AND FORCEPS. THE PROCEDURE OUTCOME IS UNKNOWN. THE FINAL PATIENT IMPACT IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8222806 ↗