PX SLIM Delivery Microcatheter PXSLIM130-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548012537), received between Feb 19, 2016 and Jul 17, 2019 — 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.

• MalfunctionJul 17, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH A PX SLIM, AND WHEN THE PHYSICIAN PULLED THE PUSHER ASSEMBLY THE PC400 UNINTENTIONALLY DETACHED. THE PHYSICIAN THEREFORE REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE SAME PX SLIM; HOWEVER, THE PHYSICIAN EXPERIENCED THE SAME RESISTANCE AND SUBSEQUENTLY THE PUSHER ASSEMBLY WAS KINKED. THE PHYSICIAN REMOVED THE PC400 AND THE PX SLIM. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH A NEW PX SLIM; HOWEVER, THE PHYSICIAN EXPERIENCED THE SAME RESISTANCE AND SUBSEQUENTLY THE PUSHER ASSEMBLY WAS ALSO KINKED. THE PHYSICIAN REMOVED THE PC400. THE PROCEDURE WAS COMPLETED USING THE PX SLIM AND NINE PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799402 ↗
• MalfunctionAug 7, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PX SLIM ALONG WITH A GUIDE WIRE THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PX SLIM BECAME STUCK WHEN IT ALMOST REACHED THE TARGET SITE; THEREFORE IT WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED A KINK ON THE PX SLIM DISTAL TIP. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7759019 ↗
• MalfunctionAug 3, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A PX SLIM INTO A NON-PENUMBRA CATHETER, THE PHYSICIAN NOTICED A KINK APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL END OF THE PX SLIM; THEREFORE, THE PX SLIM WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7749309 ↗
• MalfunctionJun 7, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT HAD A TORTUOUS ANATOMY. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PX SLIM INTO ANOTHER MANUFACTURER'S 4F CATHETER WITH A GUIDE WIRE, THE PHYSICIAN EXPERIENCED RESISTANCE AROUND THE COLOR TRANSITION PART AT THE TIP OF THE PX SLIM AND SUBSEQUENTLY, THE PX SLIM BECAME STUCK INSIDE THE 4F CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM AND THE 4F CATHETER, THEN OPENED A NEW 4F CATHETER. WHILE ATTEMPTING TO ADVANCE THE SAME PX SLIM THROUGH THE NEW 4F CATHETER, RESISTANCE WAS ENCOUNTERED AGAIN AT THE SAME POSITION AND THE PX SLIM BECAME STUCK INSIDE THE 4F CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM AND CONTINUED THE PROCEDURE BY TAKING A DIAGNOSTIC ANGIOGRAPHY THROUGH THE 4F CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6618456 ↗
• MalfunctionMay 30, 2017Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PX SLIM DELIVERY MICROCATHETER (PX SLIM) WAS FRACTURED ABOUT 50CM FROM THE TIP. THE DAMAGE TO THE PX SLIM WAS NOTICED PRIOR TO USE; THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6598411 ↗
• MalfunctionMar 1, 2017Occlusion Within Device; Physical Resistance; Occlusion Within Device; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA COIL 400''S (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED ANOTHER MANUFACTURER¿S CATHETER INTO THE TARGET VESSEL AND THEN ADVANCED A PX SLIM THROUGH IT. WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AROUND THE TIP OF THE PX SLIM AND SUBSEQUENTLY, THE PC400 BECAME STUCK. THE PHYSICIAN THEN DECIDED TO RETRACT THE PC400; HOWEVER, UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED COIL WAS REMOVED. WITH THE DEVICES OUTSIDE OF THE PATIENT'S BODY, THE PHYSICIAN ATTEMPTED TO PUSH OUT THE PC400 USING A SYRINGE BUT THE COIL DID NOT COME OUT OF THE PX SLIM. THEREAFTER, THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND 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 6370480 ↗
• MalfunctionFeb 19, 2016Physical Resistance; Material Deformation; Material Integrity Problem; Physical Resistance; Material Deformation; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE PX SLIM FROM ITS PACKAGING AND NOTICED THAT THE DISTAL TIP WAS STRAIGHT AND NOT SHAPED TO 130 DEGREES; HOWEVER, THE PHYSICIAN CONTINUED TO USE THE PX SLIM TO DEPLOY AND DETACH FIVE PC400 COILS INTO THE ANEURYSM. WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND ATTEMPTED TO RESHEATH THE COIL BY RETRACTING IT BACK INTO THE INTRODUCER SHEATH; HOWEVER, RESISTANCE WAS MET AGAIN AND BOTH THE PX SLIM AND PC400 COIL WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND A NEW PC400 COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5449156 ↗