Penumbra System PSF041Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548010427), received between Sep 24, 2015 and Oct 7, 2016 — classified as 1 death, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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. How this data works · Data updated Oct 13, 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.

• DeathOct 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A CARDIOGENIC CEREBRAL INFARCTION IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE), A PENUMBRA SYSTEM 5MAX SEPARATOR (5MAX SEPARATOR), A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) AND A PENUMBRA SYSTEM 4MAX SEPARATOR (4MAX SEPARATOR). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ASPIRATE THE THROMBUS USING THE 5MAX ACE AND 5MAX SEPARATOR BUT WAS UNSUCCESSFUL BECAUSE THE THROMBUS WAS TOO STIFF. THEREFORE, THE PHYSICIAN DECIDED TO USE ANOTHER MANUFACTURER'S RETRIEVAL DEVICE TO REMOVE THE THROMBUS; HOWEVER, WHILE USING THE RETRIEVAL DEVICE, THE PHYSICIAN NOTICED THAT A PIECE OF THE THROMBUS MIGRATED TO THE DISTAL M2 SEGMENT OF THE MCA. THE PHYSICIAN THEN SWITCHED TO THE 4MAX AND 4MAX SEPARATOR TO REMOVE THE THROMBUS IN THE M2 SEGMENT. THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN WAS ABLE TO REMOVE ALL THE THROMBUS FROM THE PATIENT. THERE WERE NO ALLEGED MALFUNCTIONS WITH THE PENUMBRA DEVICES. FOLLOWING THE PROCEDURE, THE PATIENT'S THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE IMPROVED FROM A ZERO TO A THREE, INDICATING COMPLETE PERFUSION. HOWEVER, WITHIN TWENT

  Patient problems: Death, Intrauterine Fetal; Intracranial Hemorrhage

  MAUDE report 6011845 ↗
• MalfunctionJun 14, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) FOR A CEREBRAL INFARCTION USING A PENUMBRA SYSTEM 4MAX SEPARATOR (SEP4). DURING THE PROCEDURE, THE PHYSICIAN FIRST USED ANOTHER MANUFACTURER'S THROMBECTOMY DEVICE AND THEN SWITCHED TO THE PENUMBRA DEVICES. THE SEP4 WAS INSERTED INTO A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) AND THEN A TORQUE DEVICE WAS ATTACHED TO THE SEP4. HOWEVER, UPON ATTEMPTING TO CHANGE THE POSITION OF THE TORQUE DEVICE, THE PHYSICIAN NOTICED THAT IT WAS STUCK AND UNABLE TO BE REMOVED FROM THE SEP4. THEREFORE, THE PHYSICIAN REMOVED THE SEP4 AND OPENED A NEW SEP4 AND TORQUE DEVICE FOR THE PROCEDURE. HOWEVER, THE NEW TORQUE DEVICE ALSO BECAME STUCK AND UNABLE TO BE REMOVED FROM THE SEP4. THEREFORE, THE SEP4 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE FIRST THROMBECTOMY DEVICE FROM THE OTHER MANUFACTURER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5724757 ↗
• MalfunctionJun 14, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) FOR A CEREBRAL INFARCTION USING A PENUMBRA SYSTEM 4MAX SEPARATOR (SEP4). DURING THE PROCEDURE, THE PHYSICIAN FIRST USED ANOTHER MANUFACTURER'S THROMBECTOMY DEVICE AND THEN SWITCHED TO THE PENUMBRA DEVICES. THE SEP4 WAS INSERTED INTO A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) AND THEN A TORQUE DEVICE WAS ATTACHED TO THE SEP4. HOWEVER, UPON ATTEMPTING TO CHANGE THE POSITION OF THE TORQUE DEVICE, THE PHYSICIAN NOTICED THAT IT WAS STUCK AND UNABLE TO BE REMOVED FROM THE SEP4. THEREFORE, THE PHYSICIAN REMOVED THE SEP4 AND OPENED A NEW SEP4 AND TORQUE DEVICE FOR THE PROCEDURE. HOWEVER, THE NEW TORQUE DEVICE ALSO BECAME STUCK AND UNABLE TO BE REMOVED FROM THE SEP4. THEREFORE, THE SEP4 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE FIRST THROMBECTOMY DEVICE FROM THE OTHER MANUFACTURER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5724749 ↗
• InjuryApr 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX SEPARATOR (SEP5), A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A PENUMBRA SYSTEM 4MAX SEPARATOR (SEP4). PRIOR TO THE PROCEDURE, THE PATIENT WAS GIVEN FOUR UNITS OF FRESH FROZEN PLASMA (FFP). ON THE FINAL RUN, EXTRAVASATION AT THE MCA BIFURCATION WAS NOTED AND SO 50 MG OF PROTAMINE WAS GIVEN TO REVERSE HEPARIN. THE TARGET VESSEL WAS RECANALIZED; HOWEVER, A VESSEL PERFORATION WAS IDENTIFIED, WHICH WAS RELATED TO THE DEVICES USED. A FOLLOW-UP DYNA COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED AND REVEALED A SYLVIAN SUBARACHNOID HEMORRHAGE (SAH) AND INTRAVENTRICULAR HEMORRHAGE (IVH) IN THE FOURTH VENTRICLE. ABOUT SIX HOURS LATER, A NONCONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) WAS PERFORMED AND SHOWED EVIDENCE OF SAH BUT THE IVH WAS NOT VISIBLE ANYMORE. ON POST-OPERATIVE DAY 1 ((B)(6) 2013), AN NCCT WAS PERFORMED AND STILL SHOWED THE SAH. ON POST-OPERATIVE DAY 2 ((B)(6) 2013), ANOTHER NCCT WAS PERFORMED AND SHOWED A SLIGHT HEMORRHAGIC TRANSFORMATION IN THE RIGHT CAUDATE NUCLEUS AND ONLY SLIGHT RESIDUAL SUBARACH

  Patient problems: Extravasation; Hemorrhage, Subarachnoid; Perforation of Vessels

  MAUDE report 5615379 ↗
• InjuryOct 8, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS, PENUMBRA SYSTEM 3MAX SEPARATORS, PENUMBRA SYSTEM 4MAX REPERFUSION CATHETERS, AND PENUMBRA SYSTEM 4MAX SEPARATORS. DURING THE PROCEDURE THE PATIENT EXPERIENCED A MILD VASOSPASM AT THE RIGHT MCA AND RIGHT INTERNAL CAROTID ARTERY; HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 24 HOURS POST-PROCEDURE A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) OF THE HEAD REVEALED A SUBARACHNOID HEMORRHAGE (SAH); HOWEVER, A MAGNETIC RESONANCE IMAGING (MRI) PERFORMED 3 DAYS POST PROCEDURE REVEALED AN INTRACEREBRAL HEMORRHAGE (ICH; HI-1) AND NO SAH. THE PATIENT IMPROVED CLINICALLY SEVERAL DAYS POST PROCEDURE AND WAS DISCHARGED. THE COMMITTEE REVIEWED THE EVENT AND ADJUDICATED VASOSPASM AS A NON-SERIOUS ADVERSE EVENT, PROBABLY RELATED TO THE PENUMBRA SYSTEM, DEFINITELY RELATED TO THE ANGIOGRAPHIC PROCEDURE, UNRELATED TO IVTPA, AND UNRELATED TO THE INDEX STROKE. THE COMMITTEE ADJUDICATED SAH AS A SERIOUS ADVERSE EVENT, POSSIBLY RELATED TO THE PENUMBRA SYSTEM, POSSIBLY RELATED TO THE ANGIOGRAPHIC PROCEDURE, UNRELATED TO THE INDEX STROKE AND OF UNCERTAIN RELATIONSHIP

  Patient problems: Hemorrhage, Cerebral; Hemorrhage, Subarachnoid; Vasoconstriction

  MAUDE report 5138659 ↗
• InjuryOct 8, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS, PENUMBRA SYSTEM 3MAX SEPARATORS, PENUMBRA SYSTEM 4MAX REPERFUSION CATHETERS, AND PENUMBRA SYSTEM 4MAX SEPARATORS. DURING THE PROCEDURE THE PATIENT EXPERIENCED A MILD VASOSPASM AT THE RIGHT MCA AND RIGHT INTERNAL CAROTID ARTERY; HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 24 HOURS POST-PROCEDURE A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) OF THE HEAD REVEALED A SUBARACHNOID HEMORRHAGE (SAH); HOWEVER, A MAGNETIC RESONANCE IMAGING (MRI) PERFORMED 3 DAYS POST PROCEDURE REVEALED AN INTRACEREBRAL HEMORRHAGE (ICH; HI-1) AND NO SAH. THE PATIENT IMPROVED CLINICALLY SEVERAL DAYS POST PROCEDURE AND WAS DISCHARGED. THE COMMITTEE REVIEWED THE EVENT AND ADJUDICATED VASOSPASM AS A NON-SERIOUS ADVERSE EVENT, PROBABLY RELATED TO THE PENUMBRA SYSTEM, DEFINITELY RELATED TO THE ANGIOGRAPHIC PROCEDURE, UNRELATED TO IVTPA, AND UNRELATED TO THE INDEX STROKE. THE COMMITTEE ADJUDICATED SAH AS A SERIOUS ADVERSE EVENT, POSSIBLY RELATED TO THE PENUMBRA SYSTEM, POSSIBLY RELATED TO THE ANGIOGRAPHIC PROCEDURE, UNRELATED TO THE INDEX STROKE AND OF UNCERTAIN RELATIONSHIP

  Patient problems: Hemorrhage, Cerebral; Hemorrhage, Subarachnoid; Vasoconstriction

  MAUDE report 5138649 ↗
• InjurySep 24, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX), A PENUMBRA SEPARATOR FLEX 054, A PENUMBRA SYSTEM 4MAX SEPARATOR AND A PENUMBRA SYSTEM REPERFUSION CATHETER 041. DURING THE PROCEDURE, THE PATIENT EXPERIENCED VASOSPASM OF THE RIGHT CERVICAL ICA; HOWEVER, THE PROCEDURE COMPLETED SUCCESSFULLY. THERE IS A PROBABLE RELATIONSHIP BETWEEN THE PENUMBRA DEVICES AND THE VASOSPASM HOWEVER THERE IS A DEFINITE RELATIONSHIP BETWEEN THE VASOSPASM AND THE ANGIOGRAPHIC PROCEDURE. POST PROCEDURAL ANALYSIS SHOWED NO EVIDENCE OF COMPLICATIONS TO THE PATIENT.

  Patient problems: Vasoconstriction

  MAUDE report 5102102 ↗