VisiSheath Dilator Sheath 501-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813132020378), received between Aug 28, 2018 and Mar 9, 2026 — classified as 2 deaths, 3 injuries.

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING A SPECTRANETICS GLIDELIGHT LASER SHEATH, THE RA AND LV LEAD WERE REMOVED SUCCESSFULLY. THEN, SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, ALONG WITH A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH ON THE RV LEAD, PROGRESS STALLED AT THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. WHILE UPSIZING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. THE DECISION WAS MADE TO ABANDON THE EXTRACTION PROCEDURE; THEREFORE, THE LLD EZ, ALONG WITH THE RV LEAD, WERE CUT/CAPPED AND REMAINED IN THE PATIENT (MDR#: 3007284006-2026-00066). THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD EZ. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE VISISHEATH IN USE WHEN THE PERFORATION OCCURRED, REQUIRING I

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 24548238 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA AND CIED SYSTEM/POCKET INFECTION. THE TRACTION PLATFORM MANUFACTURER/TYPE IS UNK. USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH TO REMOVE THE RV LEAD, ADVANCEMENT WAS MADE PAST THE SUPERIOR VENA CAVA (SVC); HOWEVER THE PATIENT''S BLOOD PRESSURE DROPPED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DETECTED AN EFFUSION IN THE AREA OF THE RV. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING PERICARDIOCENTESIS, BYPASS AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE RV LEAD WAS REMOVED THROUGH THE RA AND POCKET, IN TWO PIECES. THE PATIENT SURVIVED THE PROCEDURE. THE SURGEON STATED THE PERFORATION LOOKED MORE LIKE A HOLE THAN A TEAR, SO HE THOUGHT THE BEVEL OF THE VISISHEATH LIKELY CAUSED THE PERFORATION. THE RA LEAD WAS ALSO REMOVED DURING THE PROCEDURE. THIS REPORT CAPTURES THE VISISHEATH IN USE IN THE SVC WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 16988796 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A 4 YEAR OLD FRACTURED RIGHT VENTRICULAR (RV) LEAD. A SPECTRANETICS LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. A COOK MEDICAL BULLDOG LEAD EXTENDER WAS USED IN CONJUNCTION WITH THE LLD. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH. THE PHILIPS REPRESENTATIVE, PRESENT AT THE PROCEDURE, STATED THE PHYSICIAN ADVANCED HALFWAY UNDER THE CLAVICLE AND ENCOUNTERED SEVERAL ADHESIONS. THE PHYSICIAN WAS TWISTING AND PUSHING THE VISISHEATH AND BELIEVES THAT THE BEVEL OF THE VISISHEATH MAY NOT HAVE BEEN POINTED DOWN, CAUSING THE INJURY. WHEN THE PHYSICIAN REACHED THE END OF THE INNOMINATE VEIN HE CONTINUED TO ENCOUNTER RESISTANCE. WHEN THE PHYSICIAN REACHED THE AREA OF THE TRICUSPID VALVE, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION IN THE INNOMINATE VEIN WAS DISCOVERED. THE REPAIR TO THE PERFORATION WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE VISISHEATH DEVICE BEING TWISTED AND PUSHED IN THE AREA WHERE THE INNOMINATE PERFORATION

  Patient problems: Perforation of Vessels

  MAUDE report 12749334 ↗
• DeathNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE. A LEFT VENTRICULAR (LV) LEAD WAS PRESENT WITHIN THE PATIENT BUT NOT TARGETED FOR EXTRACTION. IMPLANT DURATION FOR RV AND LV WAS APPROXIMATELY 16 YEARS. GOAL WAS TO REMOVE RV LEAD, RE IMPLANT NEW RV LEAD, THEN PATIENT WAS TO HAVE MITRAL VALVE AND AORTIC VALVE REPLACEMENT THE NEXT DAY. FIRST, A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS USED WITHIN THE RV LEAD; HOWEVER THE LLD WOULD NOT GO DOWN THE LEAD BECAUSE OF THE LEAD FRACTURE IN THE SUBCLAVIAN REGION. THE PHYSICIAN THEN TRIED A DIFFERENT SIZE OF LLD. THIS LLD WENT IN AND LOCKED AS INTENDED, BUT WAS NOT LARGE ENOUGH TO SNUG THE WALLS OF THE RV LEAD. IT APPEARED TO WORK FOR A SHORT TIME WHILE INITIALLY LASING, BUT THEN THE LLD PULLED OUT OF LEAD. THE PHYSICIAN DECIDED TO USE SUTURE INSTEAD, TO PROVIDE THE TRACTION FOR LEAD REMOVAL. HE BEGAN WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND MET STALLED PROGRESSION HALFWAY DOWN BETWEEN THE POCKET AND THE SUPERIOR VENA CAVA (SVC) (LIKELY IN INNOMINATE REGION). THEN HE SWITCHED DEVICES TO A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH AND PROGRESSED AN ADDITIONAL 2 CM DOWN

  Patient problems: Death; Iatrogenic Source; Perforation of Vessels

  MAUDE report 10879980 ↗
• DeathAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PROCEDURE COMMENCED TO EXTRACT TWO LEADS: A RIGHT ATRIAL (RA) LEAD AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION AND OCCLUSION. BOTH LEADS WERE SUCCESSFULLY EXTRACTED WITH USE OF A SPECTRANETICS VISI SHEATH MODEL 501-016, A GLIDELIGHT DEVICE MODEL 500-303, TIGHTRAIL DEVICES AND A LEAD LOCKING DEVICE (LLD). HOWEVER, WHILE PLACING WIRES FOR A RE-IMPLANTATION THROUGH THE LASER AND VISI SHEATH, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING STERNOTOMY. A SUPERIOR VENA CAVA (SVC) TEAR WAS DISCOVERED. DESPITE RESCUE EFFORTS AND ATTEMPTED REPAIR OF INJURY, THE PATIENT DID NOT SURVIVE.

  Patient problems: Death; Perforation of Vessels

  MAUDE report 7825202 ↗