PX SLIM Delivery Microcatheter PXSLIM090-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548010342), received between Aug 12, 2015 and Aug 9, 2016 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2016Mechanical Problem; Physical Resistance; Mechanical Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED FRICTION AND SUBSEQUENTLY, THE COIL WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND SUCCESSFULLY DEPLOYED AND DETACHED A NEW RUBY COIL INTO THE TARGET VESSEL USING THE SAME PX SLIM. WHILE ADVANCING ANOTHER NEW RUBY COIL THROUGH THE SAME PX SLIM, THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE; HOWEVER, AFTER THE COIL WAS HALFWAY DEPLOYED INTO THE TARGET VESSEL, IT BECAME STUCK AND UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. THE PHYSICIAN WAS THEN ABLE TO SUCCESSFULLY PUSH THE DETACHED RUBY COIL INTO THE TARGET VESSEL. AFTER THIS, THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT ALTHOUGH THE PHYSICIAN DID NOT MAINTAIN A CONTINUOUS FLUSH AND DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV), A SYRINGE FLUSH WAS USED BEFORE AND AFTER EACH COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5858284 ↗
• MalfunctionJun 24, 2016Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL (LOT #F68557) INTO THE TARGET VESSEL USING THE PX SLIM BUT DID NOT LIKE POSITION OF THE COIL AND DECIDED TO REMOVE THE COIL FROM THE PATIENT. HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PX SLIM CONTAINING THE RUBY COIL WAS THEN REMOVED FROM THE PATIENT. NEXT, THE PHYSICIAN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE A NEW RUBY COIL (LOT #F68732) THROUGH IT. WHILE ADVANCING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, BOTH THE RUBY COIL AND THE PX SLIM WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW RUBY COIL (LOT #F67989) AND A LANTERN DELIVERY MICROCATHETER (LANTERN) TO CONTINUE THE PROCEDURE. WHILE THE RUBY COIL WAS BEING INTRODUCED INTO THE LANTERN, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED AND WAS THEREFORE, REMOVED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749275 ↗
• MalfunctionJun 24, 2016Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL (LOT #F68557) INTO THE TARGET VESSEL USING THE PX SLIM BUT DID NOT LIKE POSITION OF THE COIL AND DECIDED TO REMOVE THE COIL FROM THE PATIENT. HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PX SLIM CONTAINING THE RUBY COIL WAS THEN REMOVED FROM THE PATIENT. NEXT, THE PHYSICIAN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE A NEW RUBY COIL (LOT #F68732) THROUGH IT. WHILE ADVANCING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, BOTH THE RUBY COIL AND THE PX SLIM WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW RUBY COIL (LOT #F67989) AND A LANTERN DELIVERY MICROCATHETER (LANTERN) TO CONTINUE THE PROCEDURE. WHILE THE RUBY COIL WAS BEING INTRODUCED INTO THE LANTERN, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED AND WAS THEREFORE, REMOVED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749269 ↗
• MalfunctionMay 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH A PX SLIM; HOWEVER, WHILE REPOSITIONING THE RUBY COIL, IT UNINTENTIONALLY DETACHED. UPON REMOVING THE PX SLIM, THE DETACHED RUBY COIL REMAINED IN THE PATIENT AND WAS REMOVED USING A SNARE DEVICE. WHILE ADVANCING A NEW RUBY COIL THROUGH A NEW PX SLIM, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PX SLIM AND DETACHED RUBY COIL WERE BOTH REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5626213 ↗
• MalfunctionMar 29, 2016Kinked; Leak/Splash; Kinked; Leak/Splash

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL BASILAR JUNCTION USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE PX SLIM STRAIN RELIEF WAS KINKED. SHORTLY AFTER THAT, THE PHYSICIAN NOTICED THAT SALINE WAS LEAKING FROM THE AREA OF THE STRAIN RELIEF. THE PX SLIM WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5531923 ↗
• MalfunctionAug 17, 2015Detachment Of Device Component; Fracture; Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A NON-PENUMBRA DIAGNOSTICS CATHETER, THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND RUBY COILS. DURING THE PROCEDURE THE DETACHMENT HANDLE WAS DROPPED ON THE GROUND, CAUSING IT TO COME APART. THE DETACHMENT HANDLE DID NOT COME IN CONTACT WITH THE PATIENT, AND WAS DISPOSED OF AT THE HOSPITAL. IN THE SAME PROCEDURE, A RUBY COIL WAS ADVANCED INTO A PX SLIM, AND WAS KINKED DURING REMOVAL OF THE INTRODUCER SHEATH. THE RUBY COIL DID NOT COME IN CONTACT WITH THE PATIENT, AND WAS DISPOSED OF AT THE HOSPITAL. IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT TORTUOSITY, WHICH RESULTED IN TENSION IN THE SYSTEM. WHILE LOOKING FOR BETTER ACCESS INTO THE ANEURYSM, THE TENSION KICKED THE SYSTEM OUT OF THE ANEURYSM. THE PX SLIM WAS THEN KINKED WHILE ADVANCING AND BECAME STUCK INSIDE THE NON-PENUMBRA DIAGNOSTICS CATHETER. THE PHYSICIAN EXPERIENCED DIFFICULTY MOVING THE PX SLIM BACK AND FORTH; THEREFORE, THE PHYSICIAN USED EXTREME FORCE TO PULL THE PX SLIM. THE FORCE USED RESULTED IN THE PX SLIM BECOMING FRACTURED INSIDE THE NON-PENUMBRA DIAGNOSTICS CATHETER THAT WAS IN USE IN THE PATIENT. A SYRINGE WAS THEN USED AT THE SIDE OF THE HUB T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5008651 ↗
• MalfunctionAug 12, 2015Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHEN ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE PX SLIM AND THE PUSHER ASSEMBLY BECAME FRACTURED. THE PHYSICIAN WAS ADVISED TO REMOVE THE RUBY COIL TO PREVENT IT FROM DETACHING IN AN UNINTENDED AREA. BOTH RUBY COIL AND PX SLIM WERE SUCCESSFULLY REMOVED WITHOUT ANY COMPLICATION AND THE PHYSICIAN USED ANOTHER PX SLIM AND RUBY COIL TO CONTINUE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4998640 ↗