Penumbra System PSF054Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814548010434), received between Sep 24, 2015 and Oct 7, 2016 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Flaked” (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 6 most recent of 6 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 6011677 ↗
• InjuryApr 29, 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

  Patient problems: Hemorrhage, Subarachnoid; Perforation of Vessels

  MAUDE report 5619661 ↗
• InjuryApr 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX SEPARATOR (SEP5). DURING THE PROCEDURE, THE PHYSICIAN FIRST ATTEMPTED TO USE THE ADAPT TECHNIQUE (A DIRECT ASPIRATION, FIRST PASS TECHNIQUE), FOLLOWED BY ANOTHER MANUFACTURER'S DEVICE AND THEN FINALLY USED THE SEP5. THE PHYSICIAN REPORTED THAT THE SEP5 PERFORATED THE PATIENT'S MIDDLE CEREBRAL ARTERY (MCA) AND CREATED A BLEED. ANOTHER MANUFACTURER'S GUIDEWIRE WAS ALSO USED FOR THE PROCEDURE; HOWEVER, THE PHYSICIAN DOES NOT ATTRIBUTE THE PERFORATION TO THE GUIDEWIRE. THE BLEEDING RESOLVED AND THE PATIENT HAS HAD A SECOND STROKE UNRELATED TO THE PERFORATION. THE PATIENT'S HEALTH STATUS AT THE TIME WAS POOR DUE TO THE TWO STROKES AND NOT DUE TO THE SEP5.

  Patient problems: Hemorrhage, Cerebral; Perforation of Vessels

  MAUDE report 5562883 ↗
• InjuryFeb 18, 2016Flaked; Material Integrity Problem; Flaked; Material Integrity Problem

  ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: THE THROMBECTOMY PROCEDURE WAS A SUCCESS AND THE PATIENT DID VERY WELL FOR A FEW MONTHS POST TREATMENT OF THE STROKE. ANOTHER MANUFACTURER'S GUIDEWIRE WAS ALSO USED FOR THE PROCEDURE. PER THE PHYSICIAN, IT IS UNKNOWN IF THE PENUMBRA DEVICES WERE CONTRIBUTORY CAUSES TO THE NECROTIZING FOREIGN BODY IN THE PATIENT AND IT IS UNKNOWN WHAT THE CAUSE OF THE NECROTIZING FOREIGN BODY. AS OF (B)(6) 2016, THE PATIENT IS DOING BETTER.

  Patient problems: Foreign Body In Patient; Foreign Body Reaction; Necrosis

  MAUDE report 5445750 ↗
• 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 5199925 ↗
• 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 5102104 ↗