Single Use 3-Lumen Sphincterotome VRecalls & reported problems across all models
Olympus Medical Systems Corp. · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
10 open recalls name at least one Single Use 3-Lumen Sphincterotome V model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 863
- Deaths reported
- 3
- Injuries reported
- 39
- Recalls
- 10
We found 31 models of Single Use 3-Lumen Sphincterotome V by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 863 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2018 and Sep 30, 2026 — classified as 3 deaths, 39 injuries, 821 malfunctions.
The most frequently reported specific device problem is “Break” (676 reports).
10 FDA recall records name at least one of these models by its device identifier, 10 still open.
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
Single Use 3-Lumen Sphincterotome V recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1292-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1291-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1290-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1276-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1275-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1274-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1273-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1272-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1271-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Open, Classified
Devices which did not undergo thermoforming could deform and lose performance.
Z-1268-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗
Most reported Single Use 3-Lumen Sphincterotome V problems
Device problems
- Break676
- Material Split, Cut or Torn97
- Melted53
- Peeled/Delaminated45
- Detachment of Device or Device Component26
- Adverse Event Without Identified Device or Use Problem18
- Sparking15
- Poor Quality Image13
Patient problems
- No Clinical Signs, Symptoms or Conditions794
- No Consequences Or Impact To Patient39
- Pancreatitis9
- Hemorrhage/Blood Loss/Bleeding8
- Perforation8
- Foreign Body In Patient4
- Unspecified Hepatic or Biliary Problem4
- Burn(s)2
Single Use 3-Lumen Sphincterotome V models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Unit, electrosurgical, endoscopic (with or without accessories)160 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Unit, electrosurgical, endoscopic (with or without accessories)1 recall77 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0730Unit, electrosurgical, endoscopic (with or without accessories)1 recall71 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Unit, electrosurgical, endoscopic (with or without accessories)1 death118 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0720Unit, electrosurgical, endoscopic (with or without accessories)1 recall1 death62 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0720Unit, electrosurgical, endoscopic (with or without accessories)1 recall25 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0320Unit, electrosurgical, endoscopic (with or without accessories)1 recall24 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0720Unit, electrosurgical, endoscopic (with or without accessories)71 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0730Unit, electrosurgical, endoscopic (with or without accessories)64 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0320Unit, electrosurgical, endoscopic (with or without accessories)1 recall12 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0330Unit, electrosurgical, endoscopic (with or without accessories)1 recall5 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-3030Unit, electrosurgical, endoscopic (with or without accessories)1 recall3 reports
- Single Use 3-Lumen Sphincterotome V KD-V431M-0720Unit, electrosurgical, endoscopic (with or without accessories)1 recall3 reports
- Single Use 3-Lumen Sphincterotome V KD-V431M-0730Unit, electrosurgical, endoscopic (with or without accessories)1 recall3 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-1530Unit, electrosurgical, endoscopic (with or without accessories)1 recall1 report
- Single Use 3-Lumen Sphincterotome V KD-V411M-0320Unit, Electrosurgical, Endoscopic (With Or Without Accessories)1 recall1 report
- Single Use 3-Lumen Sphincterotome V KD-V411M-1520Unit, electrosurgical, endoscopic (with or without accessories)1 recall0 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-1530Unit, electrosurgical, endoscopic (with or without accessories)35 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0320Unit, electrosurgical, endoscopic (with or without accessories)1 death34 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-3030Unit, electrosurgical, endoscopic (with or without accessories)17 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0730Unit, electrosurgical, endoscopic (with or without accessories)14 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-1520Unit, electrosurgical, endoscopic (with or without accessories)12 reports
- Single Use 3-Lumen Sphincterotome V KD-V431M-0720Unit, electrosurgical, endoscopic (with or without accessories)11 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-1530Unit, electrosurgical, endoscopic (with or without accessories)9 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0330Unit, electrosurgical, endoscopic (with or without accessories)8 reports
- Single Use 3-Lumen Sphincterotome V KD-V431M-0730Unit, electrosurgical, endoscopic (with or without accessories)8 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0330Unit, electrosurgical, endoscopic (with or without accessories)7 reports
- Single Use 3-Lumen Sphincterotome V KD-V431M-0720Unit, electrosurgical, endoscopic (with or without accessories)5 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-1520Unit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use 3-Lumen Sphincterotome V KD-V411M-3030Unit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use 3-Lumen Sphincterotome V KD-V431M-0730Unit, electrosurgical, endoscopic (with or without accessories)1 report
Recent Single Use 3-Lumen Sphincterotome V adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941441 ↗MalfunctionSep 28, 2026Break
It was reported that the cutting blade broke with the Olympus Single Use Sphincterotome. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography procedure. The procedure was completed using a similar device. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914810 ↗MalfunctionSep 28, 2026Break
It was reported that the cutting wire broke after power activation with the Olympus Single Use Sphincterotome. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure. The procedure was completed using a similar device. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914222 ↗MalfunctionSep 28, 2026Break
It was reported that the cutting wire broke after power activation with the Olympus Single Use Sphincterotome. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure. The procedure was completed using a similar device. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914021 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862694 ↗MalfunctionAug 18, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305533 ↗MalfunctionApr 29, 2026Break
IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME TIP OF THE CLEVER CUT WAS GETTING DAMAGED OR BROKEN IN A SINGLE USE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029154 ↗MalfunctionApr 23, 2026Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME KNIFE WIRE WAS DAMAGED, CAUSING ENERGIZATION PROBLEMS AND LENGTHENING THE THERAPEUTIC VARICOCELECTOMY. THE PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973646 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME'S WIRE IS FRACTURED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926856 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME KNIFE WIRE WAS BROKEN. THE ISSUE WAS FOUND WHEN REMOVING THE DEVICE FROM THE BOX. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874062 ↗MalfunctionFeb 27, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471497 ↗MalfunctionFeb 27, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471376 ↗MalfunctionFeb 27, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471323 ↗MalfunctionFeb 24, 2026No Apparent Adverse Event
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431280 ↗MalfunctionFeb 19, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388149 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
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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