PX SLIM Delivery MicrocatheterRecalls & reported problems across all models

We found 9 models of PX SLIM Delivery Microcatheter by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 186 adverse event reports in the FDA's MAUDE database, received between Aug 12, 2015 and May 17, 2024 — classified as 6 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (69 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PX SLIM Delivery Microcatheter problems

PX SLIM Delivery Microcatheter models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PX SLIM Delivery Microcatheter PXSLIM045-B

  CATHETER, PERCUTANEOUS
  53 reports
• PX SLIM Delivery Microcatheter PXSLIMSTR-B

  CATHETER, PERCUTANEOUS
  46 reports
• PX SLIM Delivery Microcatheter PXSLIMSTR-A

  CATHETER, PERCUTANEOUS
  29 reports
• PX SLIM Delivery Microcatheter PXSLIM045-A

  CATHETER, PERCUTANEOUS
  26 reports
• PX SLIM Delivery Microcatheter PXSLIM090-B

  CATHETER, PERCUTANEOUS
  15 reports
• PX SLIM Delivery Microcatheter PXSLIM090-A

  CATHETER, PERCUTANEOUS
  7 reports
• PX SLIM Delivery Microcatheter PXSLIM130-B

  CATHETER, PERCUTANEOUS
  7 reports
• PX SLIM Delivery Microcatheter PXSLIMSTR

  CATHETER, PERCUTANEOUS
  2 reports
• PX SLIM Delivery Microcatheter PXSLIM130-A

  CATHETER, PERCUTANEOUS
  1 report

Recent PX SLIM Delivery Microcatheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY (BA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE PX SLIM TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE PX SLIM AT THE HUB. THEREFORE, THE PX SLIM WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347197 ↗
• MalfunctionDec 20, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT ARTERIOVENOUS FISTULA (AVF) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED PENUMBRA COIL 400S (PC400) IN THE TARGET VESSEL THEN DELIVERED A LIQUID EMBOLIC AGENT INTO THE TARGET VESSEL USING THE PX SLIM. AFTER REMOVAL OF THE PX SLIM, THE PHYSICIAN NOTICED THAT THE TIP OF THE PX SLIM HAD FRACTURED AND WAS EMBEDDED SECURELY INSIDE THE PC400 COIL PACK. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361702 ↗
• MalfunctionNov 2, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UTERINE ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE PX SLIM INTO THE TARGET VESSEL AND WHILE ATTEMPTING TO TORQUE THE PX SLIM TO SELECT THE TARGET VESSEL, THE PHYSICIAN WAS UNABLE TO TORQUE THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE PX SLIM WAS FRACTURED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059269 ↗
• MalfunctionJun 30, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT CAROTID ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS OPENING THE VALVE OF THE GUIDE CATHETER AND THE PX SLIM BROKE AT THE MID-SHAFT INTO TWO PIECES INSIDE OF THE GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE BLOOD FLOW PUSHED THE BROKEN PX SLIM OUT FROM THE GUIDE CATHETER AND THE BROKEN PIECE OF THE PX SLIM WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240097 ↗
• MalfunctionJun 12, 2023Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), PENUMBRA COIL 400 (PC400), AND A BENCHMARK BMX 81 ACCESS SYSTEM (BMX81). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400, THE PHYSICIAN FELT SOMETHING. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM AND THE PC400. UPON REMOVAL, THE PX SLIM WAS NOTICED TO BE FRACTURED INTO TWO PIECES AT THE PROXIMAL END. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE PC400 HAD BRIDGED BETWEEN THE TWO FRACTURED PIECES OF THE PX SLIM ALLOWING THE PHYSICIAN TO REMOVE THE PC400 INTACT AND THE PX SLIM TOGETHER. IT WAS ALSO REPORTED THAT THE DECISION WAS MADE TO NOT USE THE REMOVED PC400 AND THERE WAS NO DAMAGE NOTED TO THE PC400. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM, A NEW PC400, AND THE SAME BMX81. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106370 ↗
• MalfunctionMar 21, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96) AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PX SLIM BROKE IN THE RHV. THEREFORE, THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND THE SAME BMX96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585218 ↗
• MalfunctionAug 20, 2022Fracture; Leak/Splash; Material Deformation; Fracture; Leak/Splash; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE PX SLIM WAS LEAKING UPON FLUSHING IT. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE MIDSHAFT OF THE PX SLIM WAS KINKED AND FRACTURED. IT WAS REPORTED THAT THE KINKED AND FRACTURED PORTION OF THE PX SLIM WAS OUTSIDE OF THE ROTATING HEMOSTASIS VALVE (RHV) AND NEURON MAX. THEREFORE, THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM WITH THE SAME NEURON MAX AND RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263005 ↗
• MalfunctionDec 3, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT FEMORAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), PENUMBRA COIL 400 (PC400S), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A 5F GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 5F GUIDE CATHETER CLOSE TO THE FISTULA, THEN ADVANCED A PX SLIM THROUGH THE GUIDE CATHETER AND INTO THE TARGET LOCATION WITHOUT ANY ISSUE. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A PC400 WITH RESISTANCE INTO THE TARGET LOCATION USING THE PX SLIM AND DETACHED THE PC400 USING THE HANDLE. NEXT, WHILE ADVANCING ANOTHER PC400 INTO THE TARGET LOCATION USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND, THEREFORE, DECIDED TO REMOVE THE PC400 AND SAVED FOR LATER USE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PX SLIM TO LOOSEN THE RESISTANCE; HOWEVER, WHEN THE PHYSICIAN INJECTED CONTRAST THROUGH THE PX SLIM, THE MIDSHAFT OF THE PX SLIM WAS NOTICED TO BE DAMAGED. THEREFORE, THE PX SLIM WAS REMOVED AND CONFIRMED TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM, THE SAME PC400, AND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12926034 ↗
• MalfunctionNov 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PC400 INTO THE PX SLIM, THE PC400 BECAME STUCK. THEREFORE, THE PC400 WAS REMOVED. NEXT, WHILE ADVANCING A NEW PC400 INTO THE PX SLIM, THE SAME ISSUE OCCURRED, THE PC400 BECAME STUCK. THEREFORE, THE PC400 AND THE PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741066 ↗
• MalfunctionOct 1, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE DEEP AND SHALLOW FEMORAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NON-PENUMBRA GUIDING SHEATH. DURING THE PROCEDURE, WHILE ADVANCING A PX SLIM FROM THE CONTRALATERAL SIDE AND THEN TURNING FROM ONE ILIAC BRANCH TO ANOTHER, IT WAS NOTICED THAT THE MID-SHAFT OF THE PX SLIM WAS BROKEN. THEREFORE, THE PX SLIM WAS REMOVED. ON THE BACK TABLE, WHILE EXAMINING THE BROKEN PX SLIM, THE PX SLIM BROKE AGAIN IN ANOTHER AREA. THEREFORE, THE PX SLIM WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND THE SAME GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565726 ↗
• MalfunctionSep 28, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), PAC400 COIL, POD400 COIL AND PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN PLACED A FEW POD400 AND PAC400 INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE PX SLIM TO CROSS A LESION SECOND TIME, THE PROXIMAL END OF THE PX SLIM KINKED. CONSEQUENTLY, THE PAC400 AND POD400 WOULD NOT DEPLOY. THEREFORE, THE PX SLIM, PAC400 AND POD400 WERE REMOVED. IT WAS REPORTED THAT THE POD400 AND PAC400 DID NOT HAVE ANY ISSUE. NEXT, THE PHYSICIAN USED A NON-PENUMBRA MICROCATHETER AND PLACED SEVERAL SMART COILS IN THE TARGET LOCATION; HOWEVER, THE SUBSEQUENT SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NON-PENUMBRA COILS, TWO MORE SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544741 ↗
• MalfunctionJul 30, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY (ECA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE PX SLIM OVER THE GUIDEWIRE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE TIP OF THE PX SLIM WAS MISSING. THEREFORE, THE PX SLIM WAS REMOVED BY PULLING IT OUT ALONG WITH THE GUIDEWIRE. THE TIP OF THE PX SLIM WAS LATER FOUND ON THE BACK TABLE BY THE PHYSICIAN AND IT HAD DETACHED DURING PREPARATION FOR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12252207 ↗
• MalfunctionJul 16, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN USED A DUAL CATHETER APPROACH TO ACCESS THE FISTULA. WHILE TRYING TO ADVANCE THE 45 DEGREE PX SLIM SIDE BY SIDE AFTER PLACING THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE PX SLIM REACHED THE DISTAL TIP OF THE BENCHMARK MAX. SUBSEQUENTLY, PX SLIM BECAME KINKED APPROXIMATELY 3-5 CM FROM THE DISTAL END; THEREFORE, THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER STRAIGHT TIP PX SLIM, THE SAME MICROCATHETER AND THE SAME BENCHMARK MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181045 ↗
• MalfunctionJun 16, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE PROXIMAL END OF THE PX SLIM WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014224 ↗
• MalfunctionJun 16, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PELVIC VARICOSE VEINS USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A RUBY COIL, NON-PENUMBRA CATHETER AND A NON-PENUMBRA INTRODUCER SHEATH. DURING THE PROCEDURE, A PX SLIM WAS PASSED THROUGH A CATHETER TO THE PELVIC VARICOSE VEINS. NEXT, A RUBY COIL AND POLIDOCANOL WERE PLACED SUCCESSFULLY IN THE DISTAL PORTION OF THE TARGET LOCATION USING THE PX SLIM. AFTERWARDS, THE PHYSICIAN ADVANCED THE CATHETER TO THE GONADAL VEIN AND SUBSEQUENTLY, WHILE ADVANCING APPROXIMATELY FIVE CENTIMETERS OF THE PX SLIM THROUGH THE RHV OF THE CATHETER, PART OF THE PX SLIM THAT WAS OUTSIDE THE PATIENT BROKE. THEREFORE, THE BROKEN PX SLIM WAS REMOVED BY PULLING IT OUT BY HAND. AFTER THE REMOVAL, WHILE THE PHYSICIAN EXAMINED THE BROKEN PX SLIM, THE PHYSICIAN FURTHER BROKE THE PX SLIM INTO TWO ADDITIONAL PIECES. IT WAS REPORTED THAT THE PX SLIM WAS DRY. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND THE SAME INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013692 ↗

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