Penumbra System PSC041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548010328), received between Sep 24, 2015 and Sep 25, 2015 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2015Insufficient Device Problem Information

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A PENUMBRA SYSTEM 041 REPERFUSION CATHETER (041 CATHETER). DURING THE PROCEDURE, ANOTHER MANUFACTURER'S RETRIEVER WAS INITIALLY USED FOR THROMBECTOMY IN THE INTERNAL CAROTID ARTERY AND REVASCULARIZATION WAS MADE. THE PHYSICIAN THEN IDENTIFIED SOME OCCLUDED PARTS BETWEEN THE DISTAL M1 TO M2; THEREFORE, THE RETRIEVER WAS USED AGAIN BUT THERE WAS NO REVASCULARIZATION. AS A SECOND DEVICE, A 041 CATHETER WAS ADVANCED TO THE TARGET VESSEL, AND BLEEDING WAS CONFIRMED AT THE PRE ASPIRATION ANGIOGRAPHY. A BALLOON CATHETER WAS USED THEN USED FOR HEMOSTASIS AND BLEEDING WAS RESOLVED. THE PATIENTS' CONDITION DID NOT MAKE ANY CHANGE AT THAT TIME. A VERY MINOR SUBARACHNOID HEMORRHAGE (SAH) WAS FOUND. THE PATIENTS' STROKE WORSENED WHICH LED TO THE PATIENTS' DEATH THE FOLLOWING MONTH. PHYSICIAN'S COMMENT: NORMAL LOGIC WOULD BE THAT BLEEDING WAS HIGHLY LIKELY TO BE CAUSED BY THE USE OF ANOTHER MANUFACTURERS RETRIEVER AROUND THE ANEURYSM. EQUALLY, THERE ARE HIGH CHANCES THAT EITHER THE MICRO CATHETER OR THE MICRO GUIDE WIRE HAS PERFORATED. SAH WAS MINOR ENOUGH NOT TO BE THE REASON OF DEATH, BUT WORSENING OF STRO

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 5104558 ↗
• 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 5102106 ↗