Penumbra System PSR3D-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815948020900), received between Oct 3, 2019 and Oct 21, 2022 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathOct 21, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) AND THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A NON-PENUMBRA CATHETER AND A NON -PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS AND THE STROKE WAS DUE TO A PROXIMAL ICA DISSECTION NOTED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED THE FIRST PASS. WHILE RETRACTING THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RED72 WAS NOTED TO BE FRACTURED AT THE DISTAL END UNDER FLUOROSCOPY. THE PROXIMAL PART OF THE RED72 WAS REMOVED FROM THE PATIENT AND THE DISTAL PORTION WAS IN THE LEFT MCA. TO REMOVE THE DISTAL PORTION OF THE RED72, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) TO THE RIGHT ICA THROUGH THE ANTERIOR COMMUNICATING ARTERY (ACOM); HOWEVER, THE STENT PORTION OF THE PSR3D ALSO BROKE IN THE ICA WHILE ATTEMPTING TO CAPTURE THE DISTAL PART OF RED72. THE ATTEMPTS TO REMOVE THE FRACTURED PORTIONS OF RED72 AND PSR3D WERE UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMORRHAGE. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE DUE TO H

  Patient problems: Foreign Body In Patient; Intracranial Hemorrhage

  MAUDE report 15653369 ↗
• MalfunctionNov 19, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PSR3D THROUGH THE VELOCITY AND THE RED62, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE VELOCITY WAS BROKEN INTO TWO PIECES APPROXIMATELY 10 INCHES FROM THE HUB. THE PSR3D WAS THEN REMOVED AND RESHEATHED. THE PHYSICIAN THEN PULLED THE PROXIMAL END OF THE VELOCITY OUT AND REMOVED THE DISTAL END BY CLAMPING DOWN ON THE VELOCITY AT THE GROIN AND SUBSEQUENTLY BY PULLING IT OUT ALONG WITH THE RED62. IT WAS ALSO REPORTED THAT THERE WAS NO PHYSICAL DAMAGE NOTED ON THE PSR3D. THE PROCEDURE WAS COMPLETED USING A NEW VELOCITY, A NEW RED62 AND A NEW PSR3D. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849438 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A SUCCESSFUL THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA SHEATH, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT RETRIEVER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. DURING THE PROCEDURE, RE-CANALIZATION WAS ACHIEVED AFTER THREE PASSES USING THE SHEATH, GUIDEWIRE, JET7, VELOCITY, AND PSR3D. HOWEVER, THE PATIENT RE-OCCLUDED UPON COMPLETION OF AN ANGIOGRAM. THE PHYSICIAN THEN USED THE SAME SHEATH, THE SAME JET7, AND THE SAME VELOCITY TO PERFORM AN ADAPT PASS WITH NO SUCCESS. NEXT, THE PATIENT WAS GIVEN 15 MG OF VERAPAMIL WITH AN AGGRASTAT DRIP BOLUS AND THE PHYSICIAN PERFORMED INTRACRANIAL ANGIOPLASTY AND STENTING, MAKING FOUR PASSES WITH THE NON-PENUMBRA DEVICES. ALTHOUGH THE ANGIOGRAM INITIALLY SHOWED THAT THE M1 RE-CANALIZED, FIVE MINUTES LATER THE VESSEL RE-OCCLUDED, SIGNALING THAT A VASOSPASM HAD OCCURRED. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND CONTINUE TREATMENT WITH THE AGGR

  Patient problems: Vasodilatation

  MAUDE report 9662368 ↗
• InjuryNov 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 INDICATED THAT THE SERIOUS ADVERSE EVENT OF INTRACRANIAL HEMORRHAGE WAS ADJUDICATED TO BE UNRELATED TO THE PSR3D AND JET7.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9269797 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 KIT AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT SHOULD BE NOTED THAT THE EMBOLUS WAS VERY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PSR3D UP TO THE TARGET LOCATION THROUGH A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THEN USED THE PSR3D TO ENGAGE THE THROMBUS. WHILE ATTEMPTING TO RETRACT THE PSR3D, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE PSR3D WAS STUCK ON THE EMBOLUS. THEREFORE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE JET7 OVER THE PULL WIRE OF THE PSR3D TO RECAPTURE THE PSR3D; HOWEVER, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN THEN PULLED ON THE PSR3D UNTIL IT RELEASED. HOWEVER, WHEN PULLING ON THE PSR3D TO RELEASE IT, SOME INTIMA OF THE ARTERY WAS TORN OFF WHERE THE PSR3D WAS STUCK ON THE CLOT. THE JET7, PSR3D, AND NEURON MAX WERE THEREFORE REMOVED TOGETHER FROM THE PATIENT. AFTER THE JET7 WAS REMOVED FROM THE PATIENT AND INSPECTED ON THE BACK TABLE, THE PHYSICIAN NOTED THAT IT WAS ACCORDIONED ON THE DISTAL 30 CM LOCATION. THE PROCEDURE WAS THEN CONTINUED USING ANOTHE

  Patient problems: Intimal Dissection

  MAUDE report 9152404 ↗