Evolution G23749Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002237490), received between May 28, 2025 and May 28, 2025 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A GLIDELIGHT 14FR WAS USED FROM THE SUBCLAVIAN VEIN, BUT THERE WAS DIFFICULTY IN ADVANCING THE SHEATH, AND AT AROUND THE ANONYMOUS VEIN, THE GLIDELIGHT 14FR WAS SHIFTED TO A LR-EVN-SH-11.0-RL. AFTER PASSING THROUGH THE ANONYMOUS VEIN, THE LR-EVN-SH-11.0-RL WAS SHIFTED TO THE GLIDELIGHT 14FR. IT DID NOT ADVANCE FROM AROUND SUPERIOR VENA CAVA (SVC), RIGHT ATRIUM (RA) JUNCTION, AND THE GLIDELIGHT 14FR WAS REPLACED WITH A GLIDELIGHT 16FR. THE SHEATH WAS UNABLE TO ADVANCE FURTHER THAN AROUND THE DISTAL COIL OF A LEAD. THOUGH THE GLIDELIGHT 16FR WAS USED WITH AN OUTER SHEATH, THE SITUATION DID NOT CHANGE AT ALL, AND THE OUTER SHEATH GOT KINKED. THEN THE GLIDELIGHT 16FR WAS SHIFTED TO LR-EVN-13.0-RL AND THE REMOVAL WAS SUCCESSFULLY DONE. THE USER NOTED THE SLOW HEART MOVEMENT TO SUSPECT CARDIAC TAMPONADE. THE ECHO SHOWED PERICARDIAL FLUID WAS LEAKING, THEREFORE THE USER IMMEDIATELY PREPARED FOR DRAINAGE AND BEGAN TO SUCK IT OUT. AFTER WATCHING THE PATIENT CONDITION FOR ABOUT 60 MINUTES, THE USER AND THE SURGEONS DETERMINED THAT BLEEDING STOPPED, AND THEN SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (SICD) WAS PLACED.

  Patient problems: Cardiac Tamponade; Perforation of Vessels; Pericardial Effusion

  MAUDE report 22096454 ↗