Penumbra System PSS054Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548010380), received between Apr 27, 2016 and Apr 29, 2016 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 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 USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 054 SEPARATOR AND A VELOCITY DELIVERY MICROCATHETER. DURING THE PROCEDURE, RECANALIZATION WAS ACHIEVED WITHOUT ANY PROCEDURAL COMPLICATIONS. HOWEVER, ON POSTOPERATIVE DAY 1, A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) REPORTED HEMORRHAGIC TRANSFORMATION INTRACEREBRAL HEMORRHAGE (ICH) CONSIDERED TO BE A NON-SERIOUS ADVERSE EVENT RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE, BUT NOT RELATED TO THE INDEX STROKE. THE PATTERN OF THE HEMORRHAGE SUGGESTS THE POSSIBILITY OF VESSEL PERFORATION. THE PATIENT'S STAY WAS COMPLICATED BY CIRCULATORY SHOCK (HYPOVOLEMIC) ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2013. PATIENT FOLLOW-UP: ON (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH HYPOTENSION AND SEPTIC SHOCK WITH PULSELESS ELECTRICAL ACTIVITY ARREST AND WAS INTUBATED FOR AIRWAY PROTECTION DURING A CODE. THE PATIENT POST-ARREST MENTAL STATUS WAS MILDLY IMPROVED TO MINIMALLY RESPONSIVE STATE, +GAG, CORNEAL REFLEX, AND OCULOCEPHALIC, MOVING TO NOXIOUS STI

  Patient problems: Hemorrhage, Cerebral

  MAUDE report 5620157 ↗
• InjuryApr 27, 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 5613753 ↗