Penumbra Coil 400 4006U0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI M4244006U02040), received between Sep 30, 2015 and Aug 7, 2019 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2019Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400) AND PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PC400 COULD NOT BE DETACHED USING THE HANDLE. THEREFORE, THE PC400 WAS REMOVED. IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE PC400 OUT OF PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PROCEDURE WAS COMPLETED USING A NEW PC400, SAME HANDLE AND SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869688 ↗
• MalfunctionJul 2, 2018Stretched; Failure to Advance; Physical Resistance; Stretched; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A PC400 USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE MICROCATHETER AND, THEREFORE, THE PC400 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THE PC400 EMBOLIZATION COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 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 7657363 ↗
• MalfunctionJan 18, 2018Stretched; Material Deformation; Unintended Movement; Stretched; Material Deformation; Unintended Movement

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPRACLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400''S (PC400''S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THREE INITIAL PC400''S INTO THE PATIENT USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE NON-PENUMBRA BALLOON WAS PARTIALLY DEFLATED AND WHILE ATTEMPTING TO DEPLOY A NEW PC400, THE PHYSICIAN THOUGHT THAT THE COIL HAD UNINTENTIONALLY DETACHED AND STARTED PULLING BACK THE PX SLIM. HOWEVER, THE PC400 CAME WITH THE PX SLIM AND "POPPED OUT" OF THE ANEURYSM UNDER TENSION. THE PHYSICIAN REPORTED THAT THE PC400 BECAME "STRETCHED" AND WRAPPED AROUND THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE BALLOON CATHETER, PX SLIM AND PC400 ALL TOGETHER. THERE WAS NO NOTICEABLE DAMAGE TO THE PX SLIM. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL PC400''S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204179 ↗
• MalfunctionOct 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL THORACIC ARTERY USING PENUMBRA COIL 400'S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA ANGIOGRAPHIC CATHETER TOWARDS THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE THE PX SLIM THROUGH THE CATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND AFTER ADVANCING THE PX SLIM APPROXIMATELY FIFTY CENTIMETERS INTO THE CATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE PX SLIM ANY FURTHER. THE PHYSICIAN THEN SWITCHED TO ANOTHER NON-PENUMBRA ANGIOGRAPHIC CATHETER AND SUCCESSFULLY ADVANCED THE SAME PX SLIM THROUGH THE CATHETER. NEXT, THE PHYSICIAN DEPLOYED AND DETACHED NINE PC400S INTO THE TARGET VESSEL USING THE PX SLIM. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE NEW PC400 WOULD NOT ADVANCE AT ALL. THEREFORE, THE PC400 AND PX SLIM WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL PC400S AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6943279 ↗
• MalfunctionOct 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL THORACIC ARTERY USING PENUMBRA COIL 400'S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA ANGIOGRAPHIC CATHETER TOWARDS THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE THE PX SLIM THROUGH THE CATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND AFTER ADVANCING THE PX SLIM APPROXIMATELY FIFTY CENTIMETERS INTO THE CATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE PX SLIM ANY FURTHER. THE PHYSICIAN THEN SWITCHED TO ANOTHER NON-PENUMBRA ANGIOGRAPHIC CATHETER AND SUCCESSFULLY ADVANCED THE SAME PX SLIM THROUGH THE CATHETER. NEXT, THE PHYSICIAN DEPLOYED AND DETACHED NINE PC400S INTO THE TARGET VESSEL USING THE PX SLIM. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE NEW PC400 WOULD NOT ADVANCE AT ALL. THEREFORE, THE PC400 AND PX SLIM WERE BOTH REMOVED AND THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL PC400S AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6943277 ↗
• InjuryJul 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (ICA-PCOM) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, AFTER EIGHT PC400 COILS WERE DEPLOYED AND DETACHED IN THE ANEURYSM, MINIMAL THROMBUS FORMATION WAS NOTED AT THE ANEURYSM NECK. THEREFORE, THE PATIENT WAS ADMINISTERED FOUR THOUSAND UNITS OF HEPARIN AND SUBSEQUENTLY, THE THROMBUS RESOLVED. THE REPORTED MINIMAL THROMBUS FORMATION WAS ADJUDICATED TO HAVE A DEFINITE RELATIONSHIP TO THE PC400 COIL SYSTEM, AN UNRELATED RELATIONSHIP TO THE PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE DISEASE STATE.

  Patient problems: Thrombus

  MAUDE report 5824241 ↗
• MalfunctionFeb 19, 2016Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE CEREBRAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL (LOT # F63825) THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REMOVE BOTH THE PX SLIM AND THE PC400 COIL. AFTER REMOVING BOTH DEVICES FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE PC400 COIL WAS DAMAGED AND HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. A NEW PC400 COIL (LOT # F63825) WAS THEN DEPLOYED INTO THE ANEURYSM USING A NEW PX SLIM WITHOUT ANY ISSUES; HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE PC400 COIL IN THE ANEURYSM USING THE HANDLE (LOT # F31442). AFTER THREE UNSUCCESSFUL ATTEMPTS TO DETACH THE PC400 COIL USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO USE A NEW HANDLE (LOT # F31442) BUT WAS STILL UNSUCCESSFUL. THE PC400 COIL WAS THEN DETACHED MANUALLY BY THE PHYSICIAN. ANOTHER PC400 COIL (LOT # F36541) WAS THEN DEPLOYED INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AND DECIDED TO MANUALLY DETACH THE COIL. THE PRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5447949 ↗
• MalfunctionFeb 18, 2016Break; Detachment Of Device Component; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE CEREBRAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL (LOT # F63825) THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REMOVE BOTH THE PX SLIM AND THE PC400 COIL. AFTER REMOVING BOTH DEVICES FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE PC400 COIL WAS DAMAGED AND HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. A NEW PC400 COIL (LOT # F63825) WAS THEN DEPLOYED INTO THE ANEURYSM USING A NEW PX SLIM WITHOUT ANY ISSUES; HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE PC400 COIL IN THE ANEURYSM USING THE HANDLE (LOT # F31442). AFTER THREE UNSUCCESSFUL ATTEMPTS TO DETACH THE PC400 COIL USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO USE A NEW HANDLE (LOT # F31442) BUT WAS STILL UNSUCCESSFUL. THE PC400 COIL WAS THEN DETACHED MANUALLY BY THE PHYSICIAN. ANOTHER PC400 COIL (LOT # F36541) WAS THEN DEPLOYED INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AND DECIDED TO MANUALLY DETACH THE COIL. THE PRO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5446046 ↗
• MalfunctionFeb 2, 2016Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DELIVERED THREE PC400 COILS IN THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND THE PC400 COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY ADVANCED A NEW PC400 COIL IN THE ANEURYSM, HOWEVER, THE PHYSICIAN HAD DIFFICULTY PROPERLY POSITIONING THE PC400 COIL IN THE ANEURYSM AND IT UNINTENTIONALLY DETACHED. A PORTION OF THE DETACHED COIL WAS HANGING OUTSIDE THE ANEURYSM; THEREFORE, THE COIL WAS SUCCESSFULLY REMOVED USING A RESCUE DEVICE. A FINAL ANGIOGRAPHY PERFORMED CONFIRMED THE CASE WAS COMPLETED SUCCESSFULLY AND NO FURTHER ACTION WAS REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5405424 ↗
• MalfunctionFeb 2, 2016Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DELIVERED THREE PC400 COILS IN THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND THE PC400 COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY ADVANCED A NEW PC400 COIL IN THE ANEURYSM, HOWEVER, THE PHYSICIAN HAD DIFFICULTY PROPERLY POSITIONING THE PC400 COIL IN THE ANEURYSM AND IT UNINTENTIONALLY DETACHED. A PORTION OF THE DETACHED COIL WAS HANGING OUTSIDE THE ANEURYSM; THEREFORE, THE COIL WAS SUCCESSFULLY REMOVED USING A RESCUE DEVICE. A FINAL ANGIOGRAPHY PERFORMED CONFIRMED THE CASE WAS COMPLETED SUCCESSFULLY AND NO FURTHER ACTION WAS REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5404463 ↗
• InjuryDec 23, 2015Migration or Expulsion of Device; Retraction Problem; Failure to Advance; Difficult to Advance

  THE FOLLOWING IS BASED ON A LITERATURE REVIEW OF AN ARTICLE ENTITLED: NEUROFORM STENT MIGRATION DURING RETRIEVAL OF A DISPLACED PENUMBRA COIL IN ENDOVASCULAR TREATMENT OF CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM: CASE REPORT, WHICH WAS PUBLISHED IN THE JOURNAL OF NEUROENDOVASCULAR THERAPY ON AUGUST 28, 2015: ON (B)(6) 2014, THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR CAROTID COMMUNICATING ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED A STENT AT THE NECK OF THE ANEURYSM AND DELIVERED NINE PC400 COILS USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM IT STOPPED ADVANCING AFTER ABOUT 2 CM FROM THE DISTAL END OF THE PX SLIM. THE PHYSICIAN WAS UNABLE TO PULL OR PUSH THE PC400 COIL OUT OF THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PC400 COIL IN THE PATIENT AGAIN; HOWEVER, THE PX SLIM KICKED OUT OF THE ANEURYSM. WHILE SLOWLY REMOVING THE PX SLIM CONTAINING THE PC400 COIL FROM THE PATIENT, THE PC400 COIL BECAME ENTANGLED WITH THE STENT THAT WAS PREVIOUSLY PLACED AT THE NECK OF THE ANEURYSM. RETRACTION OF THE PC400 COIL MADE THE COIL-S

  Patient problems: Infarction, Cerebral

  MAUDE report 5325006 ↗
• InjuryDec 21, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT POSTERIOR INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SIX PC400 COILS INTO THE ANEURYSM WITH NO IMMEDIATE COMPLICATIONS USING THE PX SLIM. THE FOLLOWING DAY, THE PATIENT EXPERIENCED A SEVERE RIGHT POSTERIOR LIMBIC STROKE. THE EVENT REMAINED UNRESOLVED AND NO ACTIONS WERE TAKEN. THE REPORTED RIGHT POSTERIOR LIMBIC STROKE WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS AND A POSSIBLE RELATIONSHIP TO THE PX SLIM, ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM STATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 5317255 ↗
• InjuryOct 30, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). IT WAS NOTED THAT THE CERVICAL PORTION OF THE DOMINANT RIGHT VERTEBRAL ARTERY WAS SEVERELY TORTUOUS, ESPECIALLY IN THE V2 SEGMENT AT THE C4-C6 LEVEL. IN ADDITION, THE CERVICAL PORTION OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WAS MILDLY TORTUOUS AND NON-FLOW-LIMITING STENOSIS WAS VISUALIZED AT THE ORIGIN OF THE RIGHT EXTERNAL CAROTID ARTERY (ECA). DURING THE PROCEDURE, FOUR PC400 COILS WERE DELIVERED INTO THE ANEURYSM FOLLOWING PLACEMENT OF ANOTHER MANUFACTURERS' DEVICES. AFTER PLACEMENT OF THE OTHER MANUFACTURER'S DEVICE, THERE WAS NO EVIDENCE OF PARENT VESSEL INJURY, ARTERIAL DISSECTION OR DISTAL EMBOLIC EVENTS. HOWEVER, UPON REMOVAL OF THE GUIDE CATHETER, IMAGING OF THE RIGHT CERVICAL ARTERY SHOWED AN IATROGENIC DISSECTION WITHIN THE MID V2 SEGMENT AT THE LOCATION OF THE SEVERE TORTUOSITY. THE PHYSICIAN ADDRESSED THE DISSECTION BY USING ANOTHER MANUFACTURER'S DEVICE. ON POST-OPERATIVE DAY 2, THE PATIENT WAS CLINICALLY STABLE AND DISCHARGED TO AN EXTENDED CARE FACILITY. THE INVESTIGATOR ADJUDICATED THE DISSECTION TO BE OF UNCERTAIN RELATIONSHIP TO THE PC400

  Patient problems: Vascular Dissection

  MAUDE report 5193039 ↗
• InjurySep 30, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ANTERIOR CEREBRAL ARTERY (ACA)-ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THIRTEEN PC400 COILS WERE SUCCESSFULLY DEPLOYED AND DETACHED INTO THE ANEURYSM WITH NO COMPLICATIONS. APPROXIMATELY 3 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED A SEVERE ISCHEMIC STROKE IN THE LEFT ANTERIOR CEREBRAL ARTERY. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA), MAGNETIC RESONANCE IMAGING (MRI), ELECTROENCEPHALOGRAM (EEG), TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE PERFORMED AND THE PATIENT WAS TREATED WITH SIMVASTATIN. THE REPORTED ISCHEMIC STROKE RESOLVED ON (B)(6) 2013.

  Patient problems: Infarction, Cerebral

  MAUDE report 5114273 ↗