Lantern Delivery Catheter PXSLIMLAN150T90Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00814548016696), received between Nov 2, 2016 and Jul 7, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE LANTERN BECAME FRACTURED WITHIN THE DIAGNOSTIC CATHETER. WHILE REMOVING THE GUIDEWIRE, THE INNER LINING OF THE LANTERN WAS STRIPPED OUT. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22424771 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR TIBIAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COIL, NON-PENUMBRA SHEATH, NON-PENUMBRA CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS IN THE RIGHT FEMORAL ARTERY USING THE SHEATH AND ADVANCED THE ACCESS CATHETER FROM THE RIGHT FEMORAL ARTERY DOWN TO THE LEFT POPLITEAL ARTERY. NEXT, THE PHYSICIAN ADVANCED THE LANTERN OVER A GUIDEWIRE INTO THE POSTERIOR TIBIAL ARTERY AND SUCCESSFULLY PLACED A POD COIL IN THE TARGET LOCATION. IT WAS REPORTED THAT CONTRAST WAS THEN INJECTED THROUGH THE LANTERN TO CONFIRM ADEQUATE DEPLOYMENT OF THE POD COIL. AFTERWARDS, THE PHYSICIAN WAS REMOVING THE LANTERN AND NOTICED THAT THE LANTERN WAS FRACTURED. THE PHYSICIAN AND SCRUB TECHNICIAN THEN NOTICED THE FRACTURED PORTION OF THE LANTERN WAS INSIDE THE ACCESS CATHETER. THEREFORE, THE ACCESS CATHETER CONTAINING THE FRACTURED PORTION OF THE LANTERN WAS REMOVED AND THE ACCESS CATHETER WAS FLUSHED ON THE BACK TABLE TO REMOVE THE FRACTURED PORTION OF THE LANTERN. THE TARGET VESSEL WAS SUCCESSFULLY EMBOLIZED AND THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822628 ↗
• MalfunctionAug 3, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA DIAGNOSTIC CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE LANTERN WAS REMOVED FROM THE DIAGNOSTIC CATHETER. UPON REMOVAL, THE MID-SHAFT OF THE LANTERN WAS NOTICED TO BE FRACTURED. IT WAS REPORTED THE LANTERN WAS REMOVED TO ADVANCE THE GUIDEWIRE INTO THE DIAGNOSTIC CATHETER TO SELECT A DIFFERENT VESSEL. IT IS UNKNOWN IF THE LANTERN WAS REMOVED OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453676 ↗
• MalfunctionJul 24, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INTRODUCING THE LANTERN TO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE LANTERN AT THE MID-SHAFT. THEREFORE, THE LANTERN WAS REMOVED. 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 17378789 ↗
• MalfunctionDec 7, 2022Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA GUIDE SHEATH. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING AND TORQUEING THE LANTERN THROUGH THE SHEATH IN THE PATIENT¿S BODY, THE LANTERN BROKE IN HALF. THEREFORE, THE LANTERN WAS REMOVED UNDER FLUOROSCOPY BY PULLING IT WITH THE GUIDE SHEATH. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936504 ↗
• MalfunctionMar 29, 2022Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE LANTERN AND CATHETER, BUT IN THE MIDDLE OF THE PROCEDURE, THE PHYSICIAN DECIDED TO SWITCH THE CATHETER FOR A SMALLER CATHETER SINCE THE FIRST CATHETER WAS TOO STIFF AND COULD NOT BE ADVANCED DISTALLY. UPON REMOVAL OF THE LANTERN AND CATHETER, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE LANTERN WAS BROKEN. THE PHYSICIAN THEN ATTEMPTED TO CATHETERIZE THE VESSEL USING A SMALLER NON-PENUMBRA CATHETER BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO TERMINATE THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13936001 ↗
• MalfunctionDec 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE LANTERN INTO THE OPENED RHV AND, CONSEQUENTLY, KINKED THE LANTERN AT MULTIPLE LOCATIONS TOWARDS THE DISTAL END. THEREFORE, THE LANTERN WAS REMOVED. 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 12933749 ↗
• MalfunctionApr 6, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, WHILE INSERTING A LANTERN INTO THE DIAGNOSTIC CATHETER, THE PHYSICIAN OVALIZED THE DISTAL TIP OF THE LANTERN. HOWEVER, THE PHYSICIAN CONTINUED TO INSERT THE LANTERN. WHILE ADVANCING THE LANTERN THROUGH THE CURVE OF THE DIAGNOSTIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PHYSICIAN KINKED THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN. WHILE ADVANCING A NEW LANTERN WITHOUT THE USE OF A GUIDEWIRE THROUGH THE PATIENT¿S TORTUOUS ANATOMY INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE DISTAL END OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. WHILE THE PHYSICIAN ATTEMPTED TO INJECT CONTRAST THROUGH A NEW LANTERN USING A 5ML SYRINGE, THE SYRINGE BROKE, AND AFTER FORCING THE INJECTION, THE LANTERN CAME OUT OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO CATCH THE LANTERN, BUT KINKED THE LANTERN MID-SHAFT, AND THE DISTAL END OF THE LANTERN TOUCHED THE FLOOR. THEREFORE, THE LANTERN WAS NO LONGER USED. THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620429 ↗
• MalfunctionFeb 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE LANTERN DID NOT LOOK PROPERLY CONFIGURED AT 90 DEGREES UPON FROM REMOVAL FROM THE PACKAGING. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE LANTERN IN THE PATIENT; HOWEVER, THE LANTERN CONFIGURATION WAS NOT CORRECT. THEREFORE, IT WAS REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 11314581 ↗
• MalfunctionOct 23, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, IT WAS REPORTED THAT THE LANTERN BECOME BROKEN. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

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

  MAUDE report 10731216 ↗
• MalfunctionMay 24, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A LANTERN. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL AND, THEREFORE, THE RUBY COIL WAS REMOVED. UPON REMOVAL, THE PHYSICIAN REPORTED THAT THE COIL WAS "STRETCHED". THE PHYSICIAN THEN SWITCHED TO A NEW LANTERN AND ATTEMPTED TO PLACE A NEW RUBY COIL, HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THIS RUBY COIL AS WELL. THEREFORE, THE RUBY COIL WAS REMOVED, AND THE PROCEDURE ENDED AT THIS POINT, DESPITE THE LOW PACKING DENSITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640721 ↗
• MalfunctionMar 22, 2019Break; Material Perforation; Physical Resistance/Sticking; Break; Material Perforation; Physical Resistance/Sticking

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), WHILE PLACING THE LANTERN OVER A NON-PENUMBRA GUIDEWIRE, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE GUIDEWIRE WAS FOUND TO HAVE PERFORATED THROUGH THE LANTERN; CONSEQUENTLY, THE LANTERN HAD BROKEN IN HALF. THE DAMAGE TO THE LANTERN OCCURRED PRIOR TO USE AND PRIOR TO INSERTING IT INTO THE PATIENT¿S BODY; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN WITH THE SAME GUIDEWIRE.

  Patient problems: No Patient Involvement

  MAUDE report 8445147 ↗
• MalfunctionFeb 6, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT ARTERIOVENOUS (AV) FISTULAS IN THE PATIENT¿S LEG USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE VESSELS WERE DIFFICULT TO ACCESS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY POSITIONED A GUIDEWIRE, NON-PENUMBRA CATHETER, AND A LANTERN INTO THE TARGET VESSEL AND DEPLOYED FOUR RUBY COILS. THE TECHNICIAN THEN FELT RESISTANCE WHILE ADVANCING THE FIFTH RUBY COIL AND WAS ONLY ABLE TO ADVANCE 90% OF THE COIL INTO THE LANTERN BEFORE THE RUBY COIL BECAME KINKED. THE RUBY COIL WAS THEREFORE REMOVED. WHILE ADVANCING THE SIXTH RUBY COIL, THE TECHNICIAN AGAIN FELT RESISTANCE AND SAME ISSUE OCCURRED. THE SIXTH RUBY COIL WAS, THEREFORE, REMOVED. THE LANTERN WAS THEN REMOVED FROM THE PATIENT AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE LANTERN AND NO VISIBLE DAMAGE; HOWEVER, THE LANTERN WAS SET ASIDE AND A NEW LANTERN WAS USED TO CONTINUE THE PROCEDURE. THE SAME GUIDEWIRE AND THE SAME NON-PENUMBRA CATHETER WERE ALSO USED. THE PHYSICIAN THEN DECIDED TO RE-POSITION THE GUIDEWIRE, NON-PENUMBRA CATHETER, AND NEW LANTERN TOGETHER IN ORDER TO REGAIN ACCESS TO THE TARGET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313267 ↗
• MalfunctionDec 6, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR AN EMBOLIZATION PROCEDURE, TWO LANTERN DELIVERY MICROCATHETERS (LANTERN) WERE ACCIDENTALLY OVALIZED PRIOR TO USE. THEREFORE, THE LANTERNS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 8139001 ↗
• MalfunctionJan 31, 2018Difficult to Insert; Difficult to Insert

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO INSERT A LANTERN INTO A NON-PENUMBRA GUIDING CATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE LANTERN DID NOT FIT INTO THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND THE SAME GUIDING CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7232722 ↗
• MalfunctionNov 20, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING LANTERN DELIVERY MICROCATHETERS (LANTERNS), RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN PLACED AN UNKNOWN MANUFACTURER'S 5F GUIDE CATHETER IN THE TARGET VESSEL, THEN ADVANCED A LANTERN THROUGH THE CATHETER. IT WAS REPORTED THAT THE TIP OF THE LANTERN WAS INSIDE THE ANEURYSM BUT VERY CLOSE TO THE TIP OF THE GUIDE CATHETER. THE LANTERN WAS THEN MANUALLY FLUSHED AND A RUBY COIL WAS SUCCESSFULLY DEPLOYED AND DETACHED WITHOUT ANY ISSUE. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND RUBY COIL ALTOGETHER. THE PHYSICIAN THEN ADVANCED A NEW LANTERN INTO THE TARGET VESSEL AND USED A CONTINUOUS FLUSH THIS TIME. HOWEVER, WHILE ATTEMPTING TO ADVANCE TWO PODJS THROUGH THE NEW LANTERN, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE PODJS BECAME STUCK INSIDE THE NEW LANTERN. THEREFORE, THE LANTERN AND BOTH COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME GUIDE CATHETER, A NON-PENUMBRA MIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046503 ↗
• MalfunctionNov 2, 2016Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK IN THE LANTERN. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PHYSICIAN THEN PLACED A NEW LANTERN IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A NEW RUBY COIL. WHILE ADVANCING THE NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK IN THE LANTERN AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO OTHER RUBY COILS THROUGH THE LANTERN; HOWEVER BOTH RUBY COILS BECAME STUCK IN THE LANTERN AT THE SAME POINT AND THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL 16 COILS WITH THE SAME LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN MAINTAINED CONTINUOUS FLUSH THROUGH THE ROTATING HEMOSTASIS VALVE (RHV). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6073133 ↗