VISIGLIDE2Recalls & reported problems across all models
Terumo Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 6 models of VISIGLIDE2 by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2016 and Aug 7, 2026 — classified as 13 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VISIGLIDE2 problems
Device problems
- Fracture9
- Peeled/Delaminated9
- Break8
- Material Separation6
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Material Deformation1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Foreign Body In Patient8
- Insufficient Information6
- No Consequences Or Impact To Patient5
- Device Embedded In Tissue or Plaque3
- Bowel Perforation1
- No Patient Involvement1
- Pancreatitis1
VISIGLIDE2 models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VISIGLIDE2 G-260-2545AEndoscopic guidewire, gastroenterology-urology14 reports
- VISIGLIDE2 G-260-3545SEndoscopic guidewire, gastroenterology-urology7 reports
- VISIGLIDE2 G-260-2545SEndoscopic guidewire, gastroenterology-urology5 reports
- VISIGLIDE2 G-260-3545AEndoscopic guidewire, gastroenterology-urology3 reports
- VISIGLIDE2 G-260-2527AEndoscopic guidewire, gastroenterology-urology2 reports
- VISIGLIDE2 G-260-3527SEndoscopic guidewire, gastroenterology-urology2 reports
Recent VISIGLIDE2 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177164 ↗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 ↗MalfunctionJul 29, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50064327 ↗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 ↗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, 2025Break; Break
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GUIDEWIRE WAS UNABLE TO EXTEND FROM THE PAPILLOTOME CHANNEL OF THE KD-V441M AND IT BROKE 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 23802652 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionAug 23, 2023Break; Break
THE USER FACILITY REPORTED THAT THE GUIDEWIRE BROKE.THE DEVICE WAS REPORTED TO FAIL UPON INITIAL CLINICAL USE.
Patient problems: Insufficient Information
MAUDE report 17604015 ↗
Other Terumo Corporation products
All Terumo Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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