PX SLIM Delivery Microcatheter PXSLIMSTRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548012506), received between Oct 10, 2015 and Apr 27, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER, A PENUMBRA SYSTEM 3MAX SEPARATOR, A PX SLIM DELIVERY MICROCATHETER, A NEURON 6F SELECT CATHETER AND A NEURON MAX 6F 088 LONG SHEATH. ON POST-OPERATIVE DAY 1 AND DAY 3, A NON-CONTRAST COMPUTERIZED TOMOGRAPHY (NCCT) WAS PERFORMED AND REVEALED EVIDENCE OF A SUBARACHNOID HEMORRHAGE (SAH) IN THE DORSAL INSULA AND HEMORRHAGIC TRANSFORMATION. THE SAH WAS NOTED TO BE DUE TO VESSEL PERFORATION. THE PATIENT SHOWED OVERALL CLINICAL IMPROVEMENT IN NEUROLOGICAL STATUS AND WAS MAINTAINED ON DILTIAZEM AND ATENOLOL FOR ATRIAL FIBRILLATION THROUGHOUT THE HOSPITAL STAY. ON (B)(6) 2012, THE PATIENT WAS SUBSEQUENTLY DISCHARGED TO AN ACUTE REHABILITATION NURSING FACILITY. THE SAH WAS REVIEWED AND ADJUDICATED BY THE COMMITTEE TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE BUT UNRELATED TO THE INDEX STOKE.

  Patient problems: Hemorrhage, Subarachnoid; Perforation of Vessels

  MAUDE report 5612053 ↗
• InjuryOct 10, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER AND A PX SLIM DELIVERY MICROCATHETER. THE PROCEDURE WAS SUCCESSFUL AND COMPLETE VASCULARIZATION WAS RESTORED; NO PROCEDURAL COMPLICATIONS WERE REPORTED. HOWEVER, A SHORT LENGTH HIGHER GRADE STENOSIS AT THE ORIGIN OF THE HEFTY M2 BRANCH (VASOSPASM VS. DISSECTION) WAS NOTED ON THE POST-PENUMBRA SYSTEM ANGIOGRAM. THE COMMITTEE REVIEWED THE EVENT AND DETERMINED THAT THERE WAS A PRESENCE OF VASOSPASM. THE COMMITTEE ADJUDICATED VASOSPASM AS A NON-SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE PENUMBRA SYSTEM, PROBABLE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE, AND TO BE UNRELATED TO IVTPA AND TO THE INDEX STROKE.

  Patient problems: Vasoconstriction

  MAUDE report 5142421 ↗