VisiSheath Dilator Sheath 501-116Recalls & reported problems
Spectranetics Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132020408), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Great Vessel Perforation1
- Perforation of Vessels1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS ATTEMPTED TO BE INSERTED ONTO THE LEAD TO PROVIDE TRACTION, BUT WAS UNSUCCESSFUL. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH, ADVANCEMENT WAS MADE DOWN THE LEAD, BUT STALLED AT THE DISTAL END OF THE PROXIMAL COIL. WHEN REMOVING THE DEVICES, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND IT WAS SUSPECTED THERE WAS A SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION PERFORATION. MEDICATION WAS ADMINISTERED; HOWEVER, DID NOT STABILIZE THE PATIENT IMMEDIATELY. AFTER SOME TIME, THE PATIENT'S BLOOD PRESSURE INCREASED, AND THE INJURY CLOTTED AND HEALED. THE DECISION WAS MADE TO ABANDON THE LEAD TO EXTRACT AT A LATER DATE; THEREFORE, THE PATIENT WAS MONITORED AND SENT FOR IMAGING. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE VISISHEATH IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.
Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion
MAUDE report 24783462 ↗
Other Dilator, Vessel, For Percutaneous Catheterization devices
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization3 deaths108 reports
- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page