Neuron PND6F0701058MRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00814548010052), received between Sep 11, 2015 and Sep 1, 2023 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (18 reports).

1 other recall cover devices cleared under the same FDA submission (K082290); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER AND A BALLOON DEVICE. DURING THE PROCEDURE, THE NEURON MAX WAS ADVANCED TO THE CERVICAL INTERNAL CAROTID ARTERY (ICA) AND THE NEURON 070 WAS ADVANCED TO THE CAVERNOUS SEGMENT. WHILE INTRODUCING A NON-PENUMBRA MICROCATHETER AND A BALLOON DEVICE INTO THE NEURON 070, RESISTANCE WAS ENCOUNTERED AND THE PROCTOR PHYSICIAN NOTICED THAT THE NEURON 070 WAS KINKED AT THE PROXIMAL END OUTSIDE OF THE PATIENT. THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070, THE SAME NEURON MAX, THE SAME MICROCATHETER, AND THE SAME BALLOON DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671956 ↗
• MalfunctionJun 10, 2022Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND A NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, AFTER INTRODUCING THE NEURON 070 VIA THE SHORT SHEATH, THE PHYSICIAN NOTICED THAT THE PROXIMAL END CLOSE TO THE HUB OF THE NEURON 070 WAS BROKEN. SUBSEQUENTLY, IT WAS NOTICED THAT SOME BLOOD AND SALINE CAME OUT OF THE BROKEN PART OF THE NEURON 070. THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME SHORT SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14661238 ↗
• MalfunctionMar 8, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING A NEURON 070 THROUGH THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE NEURON 070 BECAME KINKED AT THE DISTAL TIP. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11434486 ↗
• MalfunctionSep 2, 2020Break; Component Missing; Material Deformation; Break; Component Missing; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INSERT THE NEURON 070 INTO THE NEURON MAX WITHOUT THE USE OF THE PEEL-AWAY SHEATH; HOWEVER, THE DISTAL END OF THE NEURON 070 BECAME KINKED AND BROKE OUTSIDE OF THE NEURON MAX. THEREFORE, THE NEURON 070 WAS REMOVED. IT WAS REPORTED THAT THE PEEL-AWAY SHEATH WAS MISSING FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10486128 ↗
• MalfunctionMay 8, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT A BRAIN EMBOLIZATION USING NEURON MAX 6F 088 LONG SHEATHS (NEURON MAX) AND A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, PRIOR TO USE, THE HOSPITAL STAFF NOTICED THAT THE DISTAL END OF A NEURON MAX WAS DAMAGED AND HAD SIGN OF CORROSION AND CRACKS UPON OPENING OF THE PACKAGING. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE AND THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN OPENED A NEW NEURON MAX AND ATTEMPTED TO ADVANCE THE NEURON 070 INTO THE NEURON MAX; HOWEVER, RESISTANCE WAS ENCOUNTERED AFTER ADVANCING THE NEURON 070 APPROXIMATELY THREE CENTIMETERS INTO THE NEW NEURON MAX AND THE NEURON 070 WOULD NOT ADVANCE FURTHER. THEREFORE, THE NEURON MAX AND NEURON 070 WERE REMOVED. THE PHYSICIAN THEN ADVANCED THE NEURON 070 INTO A NON-PENUMBRA SHEATH; HOWEVER, THE SAME ISSUE OCCURRED AND THE NEURON 070 WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH AND ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10040430 ↗
• MalfunctionApr 22, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A LEFT INTERNAL CAROTID ARTERY (ICA)-POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND A NON-PENUMBRA SHORT SHEATH. IT WAS REPORTED THAT PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHORT SHEATH AND THEN ADVANCED THE NEURON 070 INTO THE SHEATH. WHILE ADVANCING THE DISTAL END OF THE NEURON 070 APPROXIMATELY 60 CENTIMETERS INTO THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE NEURON 070 KINKED. THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME SHORT SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988660 ↗
• MalfunctionApr 22, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE NEURON 070 WITHIN THE PATIENT'S ANATOMY AND NOTICED UNDER FLUOROSCOPY THAT THE DISTAL TIP OF THE NEURON 070 WAS KINKED. THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988651 ↗
• MalfunctionJun 18, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FOUND THE DISTAL TIP OF A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) TO BE KINKED UPON REMOVAL FROM PACKAGING. THEREFORE, THE NEURON 070 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 8709548 ↗
• MalfunctionApr 24, 2019Stretched; Device Damaged Prior to Use; Stretched; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), THE TIP OF THE NEURON 070 BECAME STRETCHED UPON REMOVAL FROM THE PACKAGING. THE NEURON 070 WAS THEREFORE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 8544820 ↗
• MalfunctionDec 7, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON 070 THROUGH THE SHEATH. THE PHYSICIAN WAS THEN UNABLE TO MAKE A PASS WITH A GUIDEWIRE THROUGH THE NEURON 070, THEREFORE; THE NEURON 070 WAS REMOVED AND FOUND TO BE OVALIZED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER WITH THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144687 ↗
• MalfunctionDec 7, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, TWO NEURON 6F 070 DELIVERY CATHETERS (NEURON 070) WERE FOUND TO HAVE BENT TIPS. THE DAMAGE TO BOTH NEURON 070'S WAS FOUND PRIOR TO USE, UPON REMOVAL FROM THE PACKAGING AND, THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 8142729 ↗
• MalfunctionDec 7, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, TWO NEURON 6F 070 DELIVERY CATHETERS (NEURON 070) WERE FOUND TO HAVE BENT TIPS. THE DAMAGE TO BOTH NEURON 070S WAS FOUND PRIOR TO USE, UPON REMOVAL FROM THE PACKAGING AND, THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 8142721 ↗
• MalfunctionDec 6, 2018Material Deformation; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE DISTAL TIP OF A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE WITH THE NEURON 070 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 8137957 ↗
• MalfunctionDec 6, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE TIP OF THE NEURON 070 HAD BECOME TWISTED WHILE ADVANCING THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEURON 6F 053 DELIVERY CATHETER (NEURON 053) WITH THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8137695 ↗
• MalfunctionNov 7, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), A HOSPITAL STAFF FOUND THAT THE END OF THE NEURON 070 WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE AND; THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8048654 ↗
• MalfunctionOct 19, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) TIP WAS KINKED. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND, THEREFORE, THE NEURON 070 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7986706 ↗
• MalfunctionOct 18, 2018Device Damaged Prior to Use; Physical Resistance/Sticking; Device Damaged Prior to Use; Physical Resistance/Sticking

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN REMOVING THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) FROM THE PACKAGING MANDREL. THE TIP OF THE NEURON 070 WAS FOUND STUCK TO THE MANDREL AND, THEREFORE, THE NEURON 070 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7981385 ↗
• MalfunctionOct 18, 2018Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FOUND THE TIP OF THE NEURON 6F 070 DELIVERY CATHETER (NEURON 070) BECAME SEPARATED WITHIN THE PACKAGING SLEEVE. THE DAMAGE TO THE NEURON 070 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7979521 ↗
• MalfunctionOct 1, 2018Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) WAS KINKED AND OVALIZED AFTER FLUSH WITH HEPARIN. THE DAMAGED NEURON 070 WAS FOUND PRIOR TO USE AND, THEREFORE, THE NEURON 070 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7923316 ↗
• MalfunctionJul 24, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE NEURON 070 COMPLETELY THROUGH THE NON-PENUMBRA SHEATH, DESPITE USING A GUIDEWIRE. THEREFORE, THE NEURON 070 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE NEURON 070 WAS KINKED NEAR THE MIDDLE OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716895 ↗
• MalfunctionJun 5, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE INTERVENTIONAL RADIOLOGIST FOUND THAT THE THREE NEURON 6F 070 DELIVERY CATHETERS (NEURON 070S) WERE BROKEN AT MULTIPLE POINTS UPON REMOVAL FROM THE PACKAGING. THE DAMAGES TO THE NEURON 070S WERE FOUND PRIOR TO USE. THEREFORE, THE NEURON 070S WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7569544 ↗
• MalfunctionJun 5, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE INTERVENTIONAL RADIOLOGIST FOUND THAT THE THREE NEURON 6F 070 DELIVERY CATHETERS (NEURON 070S) WERE BROKEN AT MULTIPLE POINTS UPON REMOVAL FROM THE PACKAGING. THE DAMAGES TO THE NEURON 070S WERE FOUND PRIOR TO USE. THEREFORE, THE NEURON 070S WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7569534 ↗
• MalfunctionJun 5, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE INTERVENTIONAL RADIOLOGIST FOUND THAT THE THREE NEURON 6F 070 DELIVERY CATHETERS (NEURON 070S) WERE BROKEN AT MULTIPLE POINTS UPON REMOVAL FROM THE PACKAGING. THE DAMAGES TO THE NEURON 070S WERE FOUND PRIOR TO USE. THEREFORE, THE NEURON 070S WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070.

  Patient problems: No Patient Involvement

  MAUDE report 7569530 ↗
• MalfunctionMay 16, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE NEURON 070 BECAME KINKED AS THE PHYSICIAN WAS ADVANCING IT WITHIN THE INTERNAL CAROTID ARTERY (ICA) LOOP, AND THEREFORE THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520674 ↗
• MalfunctionApr 2, 2018Collapse; Physical Resistance; Collapse; Physical Resistance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE SUPRACLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE BUT WAS ABLE TO ADVANCE THE NEURON 070 AND THE MICROCATHETER DISTAL OF A 360 DEGREE LOOP IN THE PATIENT ANATOMY. HOWEVER, THE NEURON 070 WAS UNABLE TO STAY IN THE TARGET LOCATION AND RETRACTED TO THE CAROTID BULB AS THE MICROCATHETER WAS ADVANCED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE NEURON 070 TWICE, HOWEVER WAS UNSUCCESSFUL. THE NEURON 070 WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7390377 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082290. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2010 · Sep 22, 2009 · Terminated
  Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda,