Lantern Delivery Catheter PXSLIMLAN115T90Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548016634), received between Mar 22, 2017 and Dec 3, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionDec 3, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN FROM THE PATIENT AND ENCOUNTERED RESISTANCE DURING RETRACTION. AFTER THE LANTERN WAS REMOVED, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE LANTERN HAD UNRAVELED. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10939914 ↗
• MalfunctionMar 1, 2019Break; Break

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL TECHNICIAN REMOVED A LANTERN DELIVERY MICROCATHETER (LANTERN) FROM ITS PACKAGING AND WHILE FLUSHING, NOTICED THE TIP OF THE LANTERN HAD BROKEN OFF. THE DAMAGE TO THE LANTERN WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN.

  Patient problems: No Patient Involvement

  MAUDE report 8382079 ↗
• MalfunctionJul 27, 2018Deformation Due to Compressive Stress; Inadequate User Interface; Deformation Due to Compressive Stress; Inadequate User Interface

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A LANTERN, THE HOSPITAL TECHNOLOGIST KINKED THE RUBY COIL PUSHER ASSEMBLY; THEREFORE, IT WAS REMOVED. UPON REMOVING THE RUBY COIL, THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED THE LANTERN THAT WAS BEING USED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THREE ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7729133 ↗
• MalfunctionJun 13, 2018Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEREFORE REMOVED THE ROTATING HEMOSTATIC VALVE (RHV) TO PULL OUT THE RUBY COIL FROM THE LANTERN. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER RUBY COIL. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN THE LANTERN AND, CONSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN AGAIN WAS ABLE TO REMOVE THE RUBY COIL BY HAND AFTER REMOVING THE RHV. THE PHYSICIAN THEN SWITCHED TO A NEW LANTERN AND SUCCESSFULLY PLACED MULTIPLE RUBY COILS. HOWEVER, THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN ITS INTRODUCER SHEATH AND INTO THE LANTERN AND THOUGHT THAT THE PUSHER ASSEMBLY WAS DAMAGED, THOUGH NO SPECIFIC DAMAGE WAS NOTICED. THE PHYSICIAN THEREFORE REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD COILS, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596690 ↗
• MalfunctionMar 22, 2017Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR THE PROCEDURE, WHILE REMOVING THE METAL MEMORY STYLET FROM THE DISTAL TIP OF THE LANTERN DELIVERY MICROCATHETER (LANTERN) , THE OPERATING ROOM TECHNOLOGIST NOTICED THAT THE DISTAL PORTION OF THE LANTERN BROKE OFF WITH THE METAL STYLET. THE LANTERN BROKE PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW LANTERN.

  Patient problems: No Patient Involvement

  MAUDE report 6425966 ↗