VISIGLIDE2 G-260-2545ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04953170358241), received between Oct 12, 2016 and Aug 5, 2026 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Fracture

  Terumo Medical Corporation received an FDA MedWatch Report # 2429304-2026-00102. The event description states: " It was reported a patient was scheduled for an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure due to elevated bilirubin and being jaundiced. The ERCP was performed under general anesthesia and was unsuccessful because the submucosal injection had failed and the ampulla could not be accessed. The procedure was then converted to an Endoscopic Ultrasonography (EUS) Rendezvous. During the EUS Rendezvous, the dilated duct was accessed with a 19-gauge EUS needle. The angled single use guidewire was fed through the needle in an attempt to gain access to the bile duct. The wire was pushed into the lumen of the small bowel. At that point, the tip of the wire broke off. The case was aborted. The broken piece of the wire was left inside the patient. The patient was an inpatient and remained an inpatient after the aborted procedure. An ERCP procedure would be repeated in a few days to allow for inflammation from the submucosal injection to be reduced. Additional information about the location of the broken guidewire tip was requested. Conflicting information was rec

  Patient problems: Foreign Body In Patient

  MAUDE report 50144069 ↗
• InjuryAug 5, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50144067 ↗
• MalfunctionDec 16, 2025Peeled/Delaminated; Peeled/Delaminated

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE COATING WAS COMING OFF. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO PATIENT INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816685 ↗
• MalfunctionDec 15, 2025Peeled/Delaminated; Peeled/Delaminated

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE COATING WAS COMING OFF. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802650 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY OF SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY COMPARED WITH LARGE BALLOON SPHINCTEROPLASTY IN MANAGEMENT OF DIFFICULT BILE DUCT STONES IN A RANDOMIZED TRIAL." BACKGROUND AND AIMS: ALTHOUGH SINGLE-OPERATOR CHOLANGIOSCOPY (SOC)-GUIDED LITHOTRIPSY AND LARGE BALLOON SPHINCTEROPLASTY (LBS)-BASED TECHNIQUES ARE EFFECTIVE RESCUE MEASURES, THE IDEAL APPROACH TO MANAGEMENT OF DIFFICULT BILE DUCT STONES IS UNCLEAR. WE CONDUCTED A RANDOMIZED TRIAL TO COMPARE THE EFFECTIVENESS OF SOC-GUIDED LITHOTRIPSY AND LBS-BASED APPROACHES FOR ENDOSCOPIC MANAGEMENT OF DIFFICULT BILE DUCT STONES. METHODS: PATIENTS WITH DIFFICULT BILE DUCT STONES WHO FAILED RETRIEVAL USING BALLOON OR BASKET WERE RANDOMLY ASSIGNED TO GROUPS THAT RECEIVED SOC-GUIDED LASER LITHOTRIPSY (SOC-LL, N [33) OR LBS (N [ 33), FROM JUNE 2016 THROUGH AUGUST 2018. WHEN ASSIGNED TREATMENT WAS UNSUCCESSFUL, PATIENTS UNDERWENT MECHANICAL LITHOTRIPSY BEFORE CROSSING OVER TO THE OTHER GROUP. THE MAIN OUTCOME WAS TREATMENT SUCCESS, DEFINED AS ABILITY TO CLEAR THE DUCT IN 1 SESSION. SECONDARY OUTCOMES WERE ADVERSE EVENTS AND TREATMENT COSTS. RESULTS: A HIGHER PROPORTION OF PATIENTS

  Patient problems: Bowel Perforation; Pancreatitis; Perforation of Esophagus; Peritonitis

  MAUDE report 22929113 ↗
• InjuryJan 6, 2025Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  THE USER FACILITY REPORTED THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE GUIDEWIRE G-260-3545A HAD POOR LUBRICATION WHEN COMBINED WITH AN ANGIOGRAPHIC TUBE (ERCP CATHETER FROM MTW), LEADING TO PEELING OF OUTER JACKET AT THE DISTAL END. IT WAS REPLACED WITH A DEVICE OF THE SAME TYPE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WAS FRACTURED, AND A FRAGMENT POTENTIALLY REMAINED IN THE PATIENT; HOWEVER, THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21078500 ↗
• MalfunctionJan 1, 2025Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE WIRE COATING WAS PEELING OFF. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO A POSITIVE TEST CULTURE, SUSPECTED INFECTION, OR DEATH; HOWEVER, IT DID OCCUR DURING A PROCEDURE. THE PEELED COATING MAY HAVE REMAINED IN THE PATIENT BODY. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21050641 ↗
• InjurySep 30, 2022Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE INVOLVED VISIGLIDE WAS USED IN CONJUNCTION WITH AN MTW RING KNIFE. AN ELECTRIC CURRENT WAS SENT TO CAUSE HEATING IN THE PAPILLOTOMY ON THE HANDLE. THERE WAS INFORMATION THAT THE FRACTURED PIECE HAD DISLODGED INTO THE PATIENT'S BODY, BUT IT HAD ALREADY BEEN RETRIEVED. THEREFORE, IT WAS INFERRED THAT THE PATIENT WAS HARMED. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT'S FINAL IMPACT WAS NOT HARMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15511970 ↗
• MalfunctionOct 9, 2018Fracture; Fracture

  THE USER FACILITY REPORTED THAT WHILE THE USER WAS PREPARING FOR THE OPERATION, THE USER FOUND THAT THE HYDROPHILIC COATING OF THE DISTAL END WAS OFF AND THE CORE WIRE WAS EXPOSED. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE OUTCOME IS UNKNOWN. FINAL PATIENT IMPACT IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7946378 ↗
• MalfunctionSep 17, 2018Fracture; Fracture

  THE USER FACILITY REPORTED THE USER FOUND OUT THAT THE SINGLE USE GUIDEWIRE HYDROPHILIC COATING OF THE DISTAL END WAS OFF, AND THE CORE WIRE WAS EXPOSED DURING INSPECTION BEFORE USING. THE USER COMPLETED THE OPERATION WITH ANOTHER ONE. THERE WAS NO HUMAN INJURY. THE PATIENT WAS NOT HARMED, THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881143 ↗
• InjuryJul 11, 2018Fracture; Fracture

  THE USER FACILITY REPORTED A FRACTURE ON THE INVOLVED DEVICE THROUGH AN FDA MW5077670. THE PATIENT UNDERWENT AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY) FOR BILIARY STENT REPLACEMENT. DURING THE PROCEDURE THE GUIDE WIRES TANGLED IN THE BILIARY DUCT AND WERE UNABLE TO BE REMOVED. THE PHYSICIAN ELECTED TO CUT OFF THE WIRES AND LEAVE THEM IN PLACE. THE NEEDLE KNIFE USED TO TRIM THE WIRES BROKE AND THE LEVER WAS RETAINED IN THE PATIENT. THE PROCEDURE OUTCOME IS UNKNOWN. THE FINAL PATIENT IMPACT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7676804 ↗
• MalfunctionDec 22, 2016Fracture; Fracture

  THE USER FACILITY REPORTED A FRACTURE ON THE GUIDEWIRE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING AN ERCP CASE, THE DISTAL SEGMENT OF THE ACTUAL SAMPLE BECAME FRACTURED AS THE RESULT OF THE ACTUAL SAMPLE HAVING BEEN SUBJECTED TO TORQUE FORCE FOR SEEKING FOR MORE THAN ONE HOUR; THE PRODUCT WAS CHANGED OUT; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6197811 ↗
• MalfunctionDec 21, 2016Fracture; Fracture

  THE USER FACILITY REPORTED A FRACTURE ON THE GUIDEWIRE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER THE PLACEMENT OF ENBD, THE CUSTOMER TRIED TO WITHDRAW THE ACTUAL SAMPLE FROM THE DRAINAGE TUBE AND FOUND IT IMPOSSIBLE; THE CUSTOMER REMOVED IT FROM THE PATIENT BY WITHDRAWING THE DRAINAGE TUBE TOGETHER WITH THE ACTUAL SAMPLE FROM THE ENDOSCOPE; IT WAS REPORTED THAT THE CUSTOMER FOUND THAT A METAL PART WAS FITTED TO THE ACTUAL SAMPLE; AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6193335 ↗
• InjuryOct 12, 2016Fracture; Fracture

  THE USER FACILITY REPORTED A FRACTURE ON THE GUIDEWIRE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING A US-BD CASE, AFTER HAVING PUNCTURED THE INTRAHEPATIC BILE DUCT WITH A 19FNA NEEDLE (CONVEX) THROUGH THE GASTER, THE GUIDEWIRE IN QUESTION WAS INSERTED INTO THE NEEDLE; THE DISTAL END OF THE GUIDE WIRE HIT THE DISTAL TIP OF THE NEEDLE AND THE DISTAL SEGMENT OF THE GUIDE WIRE BECAME FRACTURED INTO THE VESSEL; IT IS UNKNOWN WHETHER THE FRACTURED SEGMENT WENT INTO THE HEPATIC SIDE OR THE BILE DUCT SIDE; AND IT WAS REPORTED THAT THE FRACTURED SEGMENT STILL REMAINS IN THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6020385 ↗