Lantern Delivery Catheter PXSLIMLAN160STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948023000), received between Jul 26, 2022 and Mar 23, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FISTULA ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA GLIDE CATHETER. DURING THE PROCEDURE, WHILE MANIPULATING THE LANTERN INTO THE DESIRED LOCATION, THE LANTERN FRACTURED NEAR THE HUB. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND A NEW NON-PENUMBRA GLIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965616 ↗
• MalfunctionDec 7, 2022Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT PULMONARY ARTERIOVENOUS MALFORMATIONS (PAVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A GUIDEWIRE. DURING THE PROCEDURE, THE LANTERN WAS USED AND UPON REMOVAL THE LANTERN WAS NOTED TO BE BROKEN AT THE HUB. THEREFORE, THE LANTERN WAS NOT USED IN THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936627 ↗
• MalfunctionJul 26, 2022Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN INTO THE 5F SELECT, THE PHYSICIAN KINKED AND FRACTURED THE MIDSHAFT OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. IT WAS ALSO REPORTED UPON INSPECTING THE LANTERN ON THE BACK TABLE, THE HOSPITAL TECHNOLOGIST BENT THE LANTERN AT THE LOCATION WHERE THE KINKED AND FRACTURED HAD OCCURRED. CONSEQUENTLY, THE HOSPITAL TECHNOLOGIST ENDED UP BREAKING THE LANTERN IN HALF. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME 5F SELECT. THERE WAS NO REPORT OF AN EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104691 ↗