Penumbra System 3MAXSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548012483), received between Oct 8, 2015 and Mar 20, 2018 — classified as 1 death, 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM 3MAX SEPARATOR (3MAXS). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA SHUTTLE GUIDING SHEATH IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN THEN ADVANCED THE 3MAXC INTO A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) OUTSIDE THE PATIENT¿S BODY. AFTER ADVANCING A NON-PENUMBRA GUIDEWIRE INTO THE PATIENT¿S BODY THROUGH THE 3MAXC, IT WAS CONFIRMED THAT THE TORQUE WAS NOT TRANSMITTED WELL WITH THE GUIDEWIRE. THEREFORE, THE PHYSICIAN SWITCHED TO A NEW GUIDEWIRE; HOWEVER, THE SAME ISSUE WAS OBSERVED. IT WAS ALSO REPORTED THAT THE 3MAXS WOULD NOT ADVANCE THROUGH THE 3MAXC; THEREFORE, THE 3MAXS AND 3MAXC WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, THE SAME GUIDEWIRE AND ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353425 ↗
• InjuryJun 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT SUCCESSFULLY UNDERWENT A THROMBECTOMY PROCEDURE USING TWO PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS (3MAX), A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) AND A PENUMBRA SYSTEM 3MAX SEPARATOR (SEP3) WITHOUT VASCULAR INJURY. THE PATIENT REMAINED INTUBATED AFTER THE PROCEDURE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WHERE BROAD-SPECTRUM ANTIBIOTICS WERE ADMINISTERED FOR SEPSIS FOR WHICH THE PATIENT WAS BEING TREATED FOR PRIOR TO THE PROCEDURE. THE PATIENT WAS ON PRESSORS TO MAINTAIN ADEQUATE BLOOD PRESSURE. LATER ON THAT SAME DAY, THE PATIENT'S HEMOGLOBIN WAS NOTED TO BE LOW AND THEREFORE, A BLOOD TRANSFUSION WAS GIVEN. THE PHYSICIAN REPORTED THIS WORSENING ANEMIA AS A SERIOUS ADVERSE EVENT (SAE) WHICH WAS DETERMINED TO BE RELATED TO THE PENUMBRA SYSTEM. TWO DAYS POST-PROCEDURE, ON (B)(6) 2014, THE PATIENT BECAME HYPOTENSIVE AND UNRESPONSIVE, REQUIRING MULTIPLE PRESSORS. THE PATIENT EVENTUALLY HAD PULSELESS ELECTRICAL ACTIVITY (PEA) AND WAS RESUSCITATED BUT CONTINUED TO BE BRADYCARDIC. THE PATIENT'S FAMILY CONSENTED TO A DO NOT RESUSCITATE (DNR) AND SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2014. PULSELESS ELECTRICAL ACTIVITY WAS

  Patient problems: Anemia

  MAUDE report 5749258 ↗
• InjuryApr 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND TWO PENUMBRA SYSTEM 3MAX SEPARATORS. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. HOWEVER, ON DAY 1 (POST - OPERATION ON (B)(6) 2014), BRAIN IMAGING REVEALED EVIDENCE OF AN INTRACEREBRAL HEMORRHAGE (ICH). THE ICH WAS REPORTED AS A NON-SERIOUS ADVERSE TERMED 'HEMORRHAGIC TRANSFORMATION' AND WAS DETERMINED TO BE POSSIBLY RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE, AND DEFINITELY RELATED TO THE INDEX STROKE. THE REPORTED PATTERN OF HEMORRHAGE ALSO SUGGESTS THE POSSIBILITY OF VESSEL PERFORATION. PATIENT FOLLOW-UP: ON POST-OPERATION DAY 7 ((B)(6) 2014), THE PATIENT WAS TRANSFERRED TO A HOSPICE CARE AND EXPIRED ON (B)(6) 2014. PROGRESSION OF THE INDEX STROKE WAS REPORTED AS THE CAUSE OF DEATH.

  Patient problems: Hemorrhage, Cerebral; Perforation of Vessels

  MAUDE report 5621362 ↗
• InjuryApr 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND TWO PENUMBRA SYSTEM 3MAX SEPARATORS. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. HOWEVER, ON DAY 1 (POST - OPERATION ON (B)(6) 2014), BRAIN IMAGING REVEALED EVIDENCE OF AN INTRACEREBRAL HEMORRHAGE (ICH). THE ICH WAS REPORTED AS A NON-SERIOUS ADVERSE TERMED 'HEMORRHAGIC TRANSFORMATION' AND WAS DETERMINED TO BE POSSIBLY RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE, AND DEFINITELY RELATED TO THE INDEX STROKE. THE REPORTED PATTERN OF HEMORRHAGE ALSO SUGGESTS THE POSSIBILITY OF VESSEL PERFORATION. PATIENT FOLLOW-UP: ON POST-OPERATION DAY 7 ((B)(6) 2014), THE PATIENT WAS TRANSFERRED TO A HOSPICE CARE AND EXPIRED ON (B)(6) 2014. PROGRESSION OF THE INDEX STROKE WAS REPORTED AS THE CAUSE OF DEATH.

  Patient problems: Hemorrhage, Cerebral; Perforation of Vessels

  MAUDE report 5621315 ↗
• InjuryApr 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 5MAX SEPARATOR, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND A PENUMBRA SYSTEM 3MAX SEPARATOR. DURING THE PROCEDURE, THERE WAS SUSPICION OF TINY VESSEL PERFORATION IN LEFT M3 SEGMENT¿DISTANT FROM THE SITE OF DEVICE PLACEMENT; HOWEVER, ANGIOGRAM WAS UNABLE TO CLEARLY CONFIRM THIS. THE FINAL RUNS SHOWED THAT THE VESSEL WAS RECANALIZED AND ALSO SHOWED A VASOSPASM. AT 14:25 HOURS, A FOLLOW UP COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED AND SHOWED A CIRCUMSCRIBED SUBARACHNOID HEMORRHAGE (SAH) AT THE LEFT INSULA. ON POSTOPERATIVE DAY 1, ANOTHER CT WAS PERFORMED AND REVEALED THAT THE SAH HAD NEARLY COMPLETELY RESOLVED AND ONLY TINY SPOTS OF SAH WAS SEEN IN LEFT DORSAL INSULA. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER. ON (B)(6) 2013, THE PATIENT WAS SEEN AGAIN FOR A FOLLOW UP VISIT AND EXAMINATION SHOWED NEUROLOGICAL AND FUNCTIONAL IMPROVEMENT. THE REPORTED VASOSPASM WAS REVIEWED AND ADJUDICATED BY THE COMMITTEE TO BE A NON-SERIOUS ADVERSE EVENT THAT WAS DEFINITELY RELATED TO THE ANGIOGRAPHIC PROCEDURE, AND UN

  Patient problems: Hemorrhage, Subarachnoid; Perforation of Vessels

  MAUDE report 5618449 ↗
• InjuryApr 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 3MAX SEPARATOR, A PX SLIM DELIVERY MICROCATHETER, A NEURON 6F SELECT CATHETER AND A NEURON MAX 6F 088 LONG SHEATH. ON POST-OPERATIVE DAY 1 AND DAY 3, A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) WAS PERFORMED AND REVEALED EVIDENCE OF A SUBARACHNOID HEMORRHAGE (SAH) IN THE DORSAL INSULA AND HEMORRHAGIC TRANSFORMATION. THE SAH WAS NOTED TO BE DUE TO VESSEL PERFORATION. THE PATIENT SHOWED OVERALL CLINICAL IMPROVEMENT IN NEUROLOGICAL STATUS AND WAS MAINTAINED ON DILTIAZEM AND ATENOLOL FOR ATRIAL FIBRILLATION THROUGHOUT THE HOSPITAL STAY. ON (B)(6) 2012, THE PATIENT WAS SUBSEQUENTLY DISCHARGED TO AN ACUTE REHABILITATION NURSING FACILITY. THE SAH WAS REVIEWED AND ADJUDICATED BY THE COMMITTEE TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE BUT UNRELATED TO THE INDEX STOKE.

  Patient problems: Hemorrhage, Subarachnoid; Perforation of Vessels

  MAUDE report 5611970 ↗
• DeathMar 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT WAS TAKEN IN FOR INTRAVASCULAR INTERVENTION. ARTERIAL PUNCTURE WAS DONE AT 11:47 HOURS AND ANGIOGRAM DEMONSTRATED LEFT M1 OCCLUSION (TICI 0). THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) AND A PENUMBRA SYSTEM 3MAX SEPARATOR (SEP3). NO PROCEDURAL COMPLICATIONS WERE REPORTED; HOWEVER, IN THE FOLLOWING DAYS AFTER THE PROCEDURE, THE PATIENT'S HEALTH STATUS DETERIORATED AND THE PATIENT REMAINED PARETIC ON THE RIGHT SIDE AND BECAME UNRESPONSIVE. WHILE THE PATIENT WAS INTUBATED ON (B)(6) 2014, HER NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) INCREASED FROM 20 TO 27. AFTER A MEETING, THE PATIENT'S FAMILY DECIDED TO MAKE THE PATIENT A DNR (DO NOT RESUSCITATE) AND TO WITHDRAW CARE; THEREFORE, THE PATIENT WAS EXTUBATED AND MAINTAINED ON A MORPHINE DRIP FOR COMFORT UNTIL SHE EXPIRED ON (B)(6) 2014. THE PATIENT'S PROGRESSION OF STROKE WAS REPORTED AS A SERIOUS ADVERSE EFFECT (SAE) AND A CAUSE OF DEATH. THE COMMITTEE ADJUDICATED THIS SAE TO HAVE A DEFINITE RELATIONSHIP TO THE INDEX STOKE AND AN UNCERTAIN RELAT

  Patient problems: Death; Ischemia; Neurological Deficit/Dysfunction

  MAUDE report 5528357 ↗
• InjuryNov 4, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER, A PENUMBRA SYSTEM 5MAX SEPARATOR, A PENUMBRA SYSTEM 3MAX SEPARATOR AND A VELOCITY DELIVERY MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY REMOVED THROMBUS AND REVASCULARIZATION WAS ESTABLISHED. HOWEVER, A 24-HOUR POST PROCEDURE NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) SCAN REVEALED MINIMAL PATCHY HEMORRHAGE WITHIN THE PUTAMEN. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2015 AND WAS DOING WELL DURING A FOLLOW-UP VISIT A MONTH LATER. THE REPORTED HEMORRHAGE RESOLVED ON (B)(6) 2015 WITHOUT FURTHER INTERVENTION. THE REPORTED HEMORRHAGE WAS DETERMINED TO BE OF MODERATE SEVERITY WITH POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND THE ANGIOGRAPHIC PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5199937 ↗
• InjuryNov 3, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND A PENUMBRA SYSTEM 3MAX SEPARATOR. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY REMOVED THROMBUS AND REVASCULARIZATION WAS ACHIEVED. HOWEVER, ON POSTOPERATIVE DAY 1 (POD1), A NONCONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) SCAN SHOWED AN EVOLVING MCA INFARCT. FOLLOW-UP IMAGING SHOWED CONTINUED EVOLUTION OF THE SUBACUTE INFARCT IN THE RIGHT MCA. BY POSTOPERATIVE DAY 3 (POD 3), A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN INDICATED INCREASED INFARCTION IN THE RIGHT POSTERIOR FRONTAL AND PARIETAL LOBE. ON (B)(6) 2014, PATIENT DIED AS A RESULT OF CONGESTIVE HEART FAILURE (CHF). THE SITE CONSIDERED THE REPORTED INCREASED INFARCTION/SUBACUTE INFARCT IN THE RIGHT MCA AS SERIOUS BUT UNRELATED TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE AND PROBABLY RELATED TO THE INDEX STROKE. THE REPORTED INCREASED INFARCTION/SUBACUTE INFARCT IN THE RIGHT MCA WAS REVIEWED AND ADJUDICATED BY THE COMMITTEE TO BE SERIOUS WITH AN UNCERTAIN RELATIONSHIP TO THE PENUMBRA SYSTEM AND THE ANGIOGRAPHIC PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE INDEX STROKE.

  Patient problems: Infarction, Cerebral

  MAUDE report 5199395 ↗
• 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. TWENTY-FOUR 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 REL

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

  MAUDE report 5138655 ↗
• InjuryOct 8, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER AND A PENUMBRA SYSTEM 3MAX SEPARATOR. THE PROCEDURE WAS SUCCESSFUL AND REVASCULARIZATION WAS ACHIEVED. HOWEVER A NONCONTRAST COMPUTED TOMOGRAPHY (NCCT) OF THE HEAD ON POD SHOWED PRESENCE OF INTRACRANIAL HEMORRHAGE. THE COMMITTEE REVIEWED THE EVENT AND DETERMINED THE EVENT TO BE A NON-SERIOUS ADVERSE EVENT. THE COMMITTEE ADJUDICATED THE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM, POSSIBLE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE, POSSIBLE RELATIONSHIP TO IVTPA, AND POSSIBLE RELATIONSHIP TO INDEX STROKE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 5138381 ↗