VisiSheath Dilator Sheath 501-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132020361), received between Mar 1, 2022 and Mar 13, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Sharp Edges; Sharp Edges

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. USING SIMPLE TRACTION ONLY, THE LV LEAD WAS REMOVED SUCCESSFULLY. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH, PRESSURE WAS APPLIED TO THE VISISHEATH AS IT ADVANCED OVER THE GLIDELIGHT IN THE SUBCLAVIAN/INNOMINATE REGIONS. AFTER PROGRESS STALLED WITHIN THE VASCULATURE, THE GLIDELIGHT AND VISISHEATH WERE REMOVED, AND IT WAS OBSERVED THAT THE DISTAL END OF THE VISISHEATH WAS BENT AND FRAYED. A NEW VISISHEATH WAS USED WITH THE SAME GLIDELIGHT, THE RV LEAD WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED CONSERVATIVELY FOR THE VISISHEATH FRAYED DISTAL TIP (POSSIBLE SHARP EDGE), POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899254 ↗
• InjuryMar 1, 2022Adverse 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 NON FUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS GLIDELIGHT LASER SHEATH ALONG WITH A SPECTRANETICS VISISHEATH DILATOR SHEATH TO ATTEMPT LEAD REMOVAL. WHILE LASING IN THE SUBCLAVIAN/INNOMINATE REGION, THE PATIENT''S BLOOD PRESSURE DROPPED AND THEN RETURNED, SO EXTRACTION PROCEDURE CONTINUED. THE TOOLS WERE ABLE TO ADVANCE TO THE SUPERIOR VENA CAVA (SVC) WHEN THE BLOOD PRESSURE DROPPED AGAIN, THEN RETURNED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED NO EFFUSION. RV LEAD WAS REMOVED AND NEW LEAD WAS IMPLANTED. THE PATIENT''S BLOOD PRESSURE DROPPED AGAIN, THEN RETURNED; HOWEVER, A PLEURAL EFFUSION WAS SEEN, ALONG WITH A PNEUMOTHORAX OF THE RIGHT LUNG. THE CT SURGEON PERFORMED A THORACOTOMY LATER THAT DAY (UNK IF IT WAS PERFORMED ON THE RIGHT OR LEFT SIDE), AND A HEMATOMA WAS DISCOVERED OVER THE SUPERIOR ASPECT OF THE SVC, WITH NO ACTIVE BLEEDING. THE AREA WAS CLOSED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE VISISHEATH DEVICE BEING USED CLOSEST TO THE WALL OF THE VESSEL WHEN T

  Patient problems: Hematoma; Pleural Effusion; Pneumothorax

  MAUDE report 13639109 ↗
• InjuryMar 1, 2022Adverse 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 TO UPGRADE A DUAL CHAMBER PACEMAKER TO A CRTD SYSTEM. THE PATIENT WAS A CONGENITAL HEART PATIENT AND DID NOT HAVE NORMAL ANATOMY. A VENOGRAM SHOWED VENOUS OCCLUSION AND AN UNIDENTIFIABLE (CONGENITAL) LARGE VERTICAL VENOUS STRUCTURE FROM THE ACCESS POINT (SUBCLAVIAN) AT THE POCKET, MOVING INFERIOR. THERE WAS ALSO A REMNANT OF A PREVIOUSLY EXTRACTED LEAD (DATE AND MODEL UNKNOWN) IN THE SUBCLAVIAN VEIN. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE RA AND RV LEADS TO PROVIDE TRACTION. FIRST, THE PHYSICIAN ATTEMPTED TO REMOVE THE RV LEAD USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH. WITH THESE DEVICES, ADVANCEMENT WAS MADE TO THE SUPERIOR VENA CAVA (SVC) REGION, BUT THE RV LEAD WAS FOUND TO BE ADHERED TO THE RA LEAD, AND BOTH LEADS PULLED BACK AND BUNCHED UP TOGETHER IN THE RIGHT ATRIUM AND SVC REGIONS. THE GLIDELIGHT DEVICE COULD NO LONGER BE ADVANCED. A WIRE WAS ADVANCED THROUGH THE GLIDELIGHT DEVICE TO OBTAIN ACCESS FOR RE-IMPLANTATION OF NEW LEADS. THE RA LEAD WAS SNARED FROM THE GROIN AND ATTEMPT WAS MADE AGAIN TO REMOVE THE RA

  Patient problems: Perforation of Vessels

  MAUDE report 13637432 ↗