ArtemisRecalls & reported problems across all models

We found 2 models of Artemis by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2017 and Dec 31, 2025 — classified as 4 deaths, 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (4 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 Artemis problems

Artemis models

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

• Artemis AP28-A

  Endoscope, Neurological
  4 deaths31 reports
• Artemis AP21-A

  Endoscope, Neurological
  1 report

Recent Artemis adverse event reports

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

• InjuryDec 31, 2025Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THE CASE WAS NEARLY COMPLETE WHEN THE ARTEMIS BECAME CLOGGED AFTER APPROXIMATELY NINETY MINUTES OF USE. AT THAT POINT, THE PHYSICIAN REALIZED THEY WERE ON THE WRONG TRAJECTORY AND NOTICED A VESSEL INJURY TO THE RIGHT A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). THE CLOGGED ARTEMIS WAS REMOVED AND REPLACED WITH A NEW DEVICE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. TO ADDRESS THE VESSEL INJURY, THE PHYSICIAN PERFORMED IRRIGATION AND ELECTRO-CAUTERY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT STATUS.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 23936906 ↗
• DeathJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A MICRO NEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). ON (B)(6) 2023, WE RECEIVED A NOTIFICATION FROM THE CLINICAL TEAM THAT AN INTRAOPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A RIGHT THALAMIC POSTERIOR LIMB INTERNAL CAPSULE HEMORRHAGE. A NEW BLEED WAS ALSO NOTICED IN THE OPPOSITE HEMISPHERE FROM SURGICAL SITE. THE PATIENT EXPIRED ON (B)(6) 2023. THE HEMORRHAGE AND DEATH WERE REPORTED TO HAVE A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17330250 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT A MICRO NEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS NO SUCTION AND THAT THE ARTEMIS HAD BECOME CLOGGED AFTER FIVE MINUTES OF USE. THEREFORE, THE ARTEMIS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. ON (B)(6) 2023, A SECOND NOTIFICATION WAS RECEIVED FROM THE CLINICAL TEAM REPORTING THAT AN INTRAOPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN TAKEN ON (B)(6) 2022 REVEALED A RECURRENT HEMORRHAGE LARGER THAN THE PRIOR HEMORRHAGE. THE CRANIOTOMY WAS THEN EXTENDED, AND NAVIGATION WAS USED FOR A NEW ENTRY POINT AND CRANIOTOMY DEFECT WAS ENLARGED. A FULL 3CM CRANIOTOMY WAS PERFORMED. THE ENTRY POINT WAS THE SUPERIOR FRONTAL SULCUS. SUCTION WAS ADVANCED INTO THE CLOT AND USED TO REMOVE THE CLOT. BIPOLAR CAUTERY WAS USED FOR HEMOSTASIS. THE RECURRENT HEMORRHAGE WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16339687 ↗
• DeathJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 23-MAR-2021, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING ARTEMIS NEURO EVACUATION DEVICE. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2021, THE PATIENT¿S POST-PROCEDURE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED INTRAVENTRICULAR HEMORRHAGE (IVH) IN THE BILATERAL FRONTAL HORNS, THALAMIC ICH, AND RIGHT SYLVIAN SUBARACHNOID HEMORRHAGE (SAH). ON (B)(6) 2021, A FOLLOW UP CT HEAD SCAN DEMONSTRATED STABLE RESIDUAL IVH. ON (B)(6) 2021, UPON USAGE OF EXTERNAL VENTRICULAR DRAIN (EVD), A CT SCAN SHOWED REDEMONSTRATION OF BLOOD PRODUCTS ALONG THE ROUTE OF A PREVIOUS VENTRICULOSTOMY CATHETER. BLOOD PRODUCTS ADJACENT TO THE LEFT THALAMUS AND A SMALL VOLUME OF IVH OF THE LEFT OCCIPITAL HORN WERE ALSO FOUND. ON (B)(6) 2021, AFTER THE INDEX PROCEDURE, THE PATIENT IMPROVED AND WAS MEDICALLY AND NEUROSURGICALLY CLEARED FOR DISCHARGE TO ACUTE NURSING REHABILITATION WITH PLANS TO CONTINUE LOVENOX (ENOXAPARIN) TO COUMADIN BRIDGE. ON (B)(6) 2021, THE PATIENT WAS FOUND TO BE IN RESPIRATORY DISTRESS WITH SEPSIS AND SEPTIC SHOCK. THE PATIENT WAS INTUBATED, TREATED WITH VASOPRESSORS AND ANTIBIOTICS, AND A CT HEAD WAS SUGGESTIVE FOR MASSIV

  Patient problems: Intracranial Hemorrhage

  MAUDE report 14692161 ↗
• DeathDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MINIMALLY INVASIVE SURGERY (MIS) PROCEDURE IN THE RIGHT PARIETAL AND OCCIPITAL LOBES USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THE ULTRASOUND DURING THE PROCEDURE SHOWED GOOD EVACUATION OF THE HEMORRHAGE, AND NO PROCEDURAL COMPLICATIONS WERE REPORTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND REMAINED INTUBATED AND SEDATED WHILE BEING TRANSFERRED FOR A ROUTINE POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD. THE CT SCAN REVEALED A LARGE RE-HEMORRHAGE AT THE SAME SITE WITH EXTENSION INTO THE RIGHT VENTRICLE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM (OR) AND UNDERWENT A RIGHT CRANIOTOMY, EVACUATION OF THE RE-HEMORRHAGE, AND INSERTION OF AN EXTERNAL VENTRICULAR DRAIN (EVD). THE PATIENT WAS THEN TRANSFERRED TO THE NEUROLOGICAL CRITICAL CARE UNIT (NCCU). ON (B)(6) 2021, THE PATIENT DEMONSTRATED A WORSENING IN HIS NEUROLOGICAL EXAMINATION. IMMEDIATELY FOLLOWING THIS, THE PATIENT HAD A CT DEMONSTRATING NEW AREAS OF HEMORRHAGE AND EXTENSIVE EDEMA LATERAL TO THE PRIMARY HEMORRHAGE WITHIN THE PARIETAL LOBE WITH MARKED ASSOCIATED MIDLINE SHIFT. THE PATIENT WAS TRANSFERRED TO THE OR FOR ANOTHER CRANIOTOMY AND HEMOR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12981477 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MICRO NEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE. ON (B)(6) 2021, THE COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED POST MIS PROCEDURE REVEALED A TINY AMOUNT OF BLOOD WITHIN THE DEPENDENT PORTIONS OF THE LATERAL VENTRICLES. THERE WAS RIGHTWARD DISPLACEMENT AND COMPRESSION OF THE LATERAL AND 3RD VENTRICLES. IT SHOULD BE NOTED THAT NO ACTION WAS TAKEN TO TREAT THE INTRAVENTRICULAR HEMORRHAGE (IVH). HOWEVER, THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021 AND THE PATIENT WAS DISCHARGED TO SKILLED NURSING FACILITY ON (B)(6) 2021 FOR MEDICAL MANAGEMENT. THE CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATED THE INTRAVENTRICULAR HEMORRHAGE (IVH) AS AN ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX INTRACEREBRAL HEMORRHAGE (ICH) AND THE INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 12840804 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). ON 18-MAY-2021, THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN INTERVAL INCREASE IN SIZE OF RIGHT BASAL GANGLIA HEMATOMA AND INCREASED ASSOCIATED MASS EFFECT COMPARED TO THE (B)(6) 2021 EXAM, WITH SUSPECTED INTERVAL REBLEEDING. IT SHOULD BE NOTED THAT A FOLLOW-UP CT SCAN WAS DONE ON (B)(6) 2021 AND THE INTERVAL REBLEEDING WAS RESOLVED. INCREASE IN SIZE OF RIGHT BASAL GANGLIA HEMATOMA WAS ADJUDICATED TO BE AN ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX PROCEDURE, THE INDEX INTRACEREBRAL HEMORRHAGE (ICH) AND TO THE COMORBIDITY BY THE CLINICAL EVENTS COMMITTEE (CEC). ON 02-NOV-2021, WE RECEIVED AN UPDATE INDICATING THAT THE CLINICAL EVENTS COMMITTEE (CEC) DETERMINED THE INTRACRANIAL HEMORRHAGE TO BE AN ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX PROCEDURE AND THE INDEX INTRACEREBRAL HEMORRHAGE (ICH).

  Patient problems: Hematoma

  MAUDE report 12110517 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2021, THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A WORSENING OF THE INTRAVENTRICULAR HEMORRHAGE (IVH). IT SHOULD BE NOTED THAT NO ACTION WAS TAKEN TO TREAT THE WORSENING OF THE IVH. ON (B)(6) 2021, THE PATIENT EXPIRED DUE TO CARDIOPULMONARY ARREST. THE PATIENT''S DEATH WAS REPORTED TO BE UNRELATED TO THE ARTEMIS. THE WORSENING OF THE IVH WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND INDEX PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11901154 ↗
• MalfunctionMay 13, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO TREAT THE RIGHT FRONTAL INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE ARTEMIS BIDENT WAS NO LONGER TURNING AND THAT THERE WAS NO INDICATOR SOUND COMING FROM THE ARTEMIS. THEREFORE, THE ARTEMIS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821524 ↗
• MalfunctionMay 4, 2021Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ARTEMIS WAND WAS ADVANCED THROUGH THE ENDOSCOPE TO THE HEMATOMA AND CLOT EVACUATION WAS INITIATED. SUBSEQUENTLY, SIGNIFICANT ARTERIAL BLEEDING WAS ENCOUNTERED. IRRIGATION WAS CONTINUED AND SEVERAL ATTEMPTS TO CAUTERIZE THE BLEED WERE PERFORMED; HOWEVER, THE BLEEDING CONTINUED. THE ARTEMIS THEN BECAME CLOGGED AND WOULD NOT ASPIRATE. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WAND AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. WHILE USING THE NEXT TWO CONSECUTIVE ARTEMIS DEVICES THEY BECAME CLOGGED. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WANDS; THEREFORE, THEY WERE REMOVED FROM THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM IN STABLE CONDITION FOR AN OPEN CRANIOTOMY. DURING THE OPERATION, THE PHYSICIAN DETERMINED THAT THE HEMORRHAGE WAS A RUPTURED ARTERIOVENOUS MALFORMATION (AVM). ATER OPERATING FOR SOME TIME, ADEQUATE HEMOSTASIS WAS ACHIEVED AND THE OPERATION WAS ENDED. ON (B)(6) 2021, THE SITE DECIDED THAT THE AVM RUPTURE WAS A SERIOUS ADVERSE EVENT THAT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769818 ↗
• MalfunctionMay 4, 2021Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ARTEMIS WAND WAS ADVANCED THROUGH THE ENDOSCOPE TO THE HEMATOMA AND CLOT EVACUATION WAS INITIATED. SUBSEQUENTLY, SIGNIFICANT ARTERIAL BLEEDING WAS ENCOUNTERED. IRRIGATION WAS CONTINUED AND SEVERAL ATTEMPTS TO CAUTERIZE THE BLEED WERE PERFORMED; HOWEVER, THE BLEEDING CONTINUED. THE ARTEMIS THEN BECAME CLOGGED AND WOULD NOT ASPIRATE. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WAND AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. WHILE USING THE NEXT TWO CONSECUTIVE ARTEMIS DEVICES THEY BECAME CLOGGED. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WANDS; THEREFORE, THEY WERE REMOVED FROM THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM IN STABLE CONDITION FOR AN OPEN CRANIOTOMY. DURING THE OPERATION, THE PHYSICIAN DETERMINED THAT THE HEMORRHAGE WAS A RUPTURED ARTERIOVENOUS MALFORMATION (AVM). ATER OPERATING FOR SOME TIME, ADEQUATE HEMOSTASIS WAS ACHIEVED AND THE OPERATION WAS ENDED. ON (B)(6) 2021, THE SITE DECIDED THAT THE AVM RUPTURE WAS A SERIOUS ADVERSE EVENT THAT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769806 ↗
• MalfunctionMay 4, 2021Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ARTEMIS WAND WAS ADVANCED THROUGH THE ENDOSCOPE TO THE HEMATOMA AND CLOT EVACUATION WAS INITIATED. SUBSEQUENTLY, SIGNIFICANT ARTERIAL BLEEDING WAS ENCOUNTERED. IRRIGATION WAS CONTINUED AND SEVERAL ATTEMPTS TO CAUTERIZE THE BLEED WERE PERFORMED; HOWEVER, THE BLEEDING CONTINUED. THE ARTEMIS THEN BECAME CLOGGED AND WOULD NOT ASPIRATE. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WAND AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. WHILE USING THE NEXT TWO CONSECUTIVE ARTEMIS DEVICES THEY BECAME CLOGGED. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WANDS; THEREFORE, THEY WERE REMOVED FROM THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM IN STABLE CONDITION FOR AN OPEN CRANIOTOMY. DURING THE OPERATION, THE PHYSICIAN DETERMINED THAT THE HEMORRHAGE WAS A RUPTURED ARTERIOVENOUS MALFORMATION (AVM). ATER OPERATING FOR SOME TIME, ADEQUATE HEMOSTASIS WAS ACHIEVED AND THE OPERATION WAS ENDED. ON (B)(6) 2021, THE SITE DECIDED THAT THE AVM RUPTURE WAS A SERIOUS ADVERSE EVENT THAT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769805 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2020, THE PATIENT DISPLAYED A SLIGHT INCREASED PROMINENCE OF THE LATERAL VENTRICLES AND AN INTRAVENTRICULAR RE-HEMORRHAGE IN THE OCCIPITAL HORNS WAS NOTED. HOWEVER, THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2020. ON (B)(6) 2020 WE WERE MADE AWARE THAT THE CEC ADJUDICATED THE RE-HEMORRHAGE TO BE A SERIOUS ADVERSE EVENT RELATED TO ARTEMIS, TO THE PROCEDURE, TO THE PATIENT¿S COMORBIDITY, AND TO THE INDEX INTRACRANIAL HEMORRHAGE (ICH). ON (B)(6) 2021, WE WERE MADE AWARE THAT THE PATIENT SUFFERED HYDROCEPHALUS ON (B)(6) 2020. THE COMPUTED TOMOGRAPHY SCAN (CT) REVEALED WORSENING EXTRA-AXIAL COLLECTION AND LEFT CEREBRAL CONVEXITY, AS WELL AS WORSENING MIDLINE SHIFT AND VENTRICULAR DILATATION. IT WAS ALSO NOTED THAT THERE WAS PROBABLY TRANSEPENDYMAL FLOW CEREBROSPINAL FLUID (CSF). A MEDICAL PROCEDURE WAS PERFORMED TO TREAT THE HYDROCEPHALUS AND THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2020. THE CEC ADJUDICATED THE HYDROCEPHALUS TO BE A SERIOUS ADVERSE EVENT RELATED

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hydrocephalus

  MAUDE report 11412685 ↗
• MalfunctionNov 20, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO EVACUATE A HEMATOMA USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, WHILE ATTEMPTING TO USE THE ARTEMIS WITHIN THE PATIENT, THE PHYSICIAN NOTICED THE ARTEMIS ASPIRATION WAS WEAK. THE PHYSICIAN RESET THE ARTEMIS TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE ARTEMIS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10880250 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A MEDICAL PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). AFTER BLOOD EVACUATION WITH THE ARTEMIS, EVIDENCE OF A NEW ISCHEMIC STROKE WAS DETERMINED ON COMPUTERIZED TOMOGRAPHY (CT) SCANS. POSTOPERATIVE SEIZURES WERE LIKELY DUE TO THIS STROKE. IN ADDITION, HOLOCEPHALIC LEFT SUBDURAL HEMATOMA WAS LIKELY THE CAUSE OF THE LEFT HEMISPHERIC FOCAL STATUS EPILEPTICUS. THE EVENTS WERE CONSIDERED UNRESOLVED AT THE TIME OF THE STUDY. ON (B)(6) 2019, THE PATIENT EXPIRED FROM SEPSIS IN THE SETTING OF THE ICH. THE PATIENT'S DEATH WAS UNRELATED TO THE ARTEMIS. THE ISCHEMIC STROKE WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX ICH, THE INDEX PROCEDURE, AND COMORBIDITY. THE SUBDURAL HEMATOMA WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT RELATED TO THE ARTEMIS AND INDEX PROCEDURE.

  Patient problems: Hematoma; Ischemia Stroke

  MAUDE report 10830888 ↗

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