Penumbra System PSC032Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548010311), received between Oct 9, 2015 and Oct 9, 2015 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K072718); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 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 REPERFUSION CATHETER 032, A PENUMBRA SYSTEM REPERFUSION CATHETER 054, AND A PENUMBRA SYSTEM SEPARATOR 032. MECHANICAL THROMBECTOMY WAS DONE WITH THE PENUMBRA SYSTEM WITHOUT VESSEL INJURY. THE PHYSICIAN USED ANOTHER MANUFACTURER'S DEVICE FOLLOWED BY ADMINISTRATION OF REOPRO (ABCIXIMAB) AND TISSUE PLASMINOGEN ACTIVATOR (TPA) FOR A DISTAL OCCLUSION IN THE LEFT M2 BRANCH AND REVASCULARIZATION WAS ACHIEVED. AFTER THE ADDITIONAL INTERVENTIONS, A VASOSPASM IN THE CERVICAL ICA AND A NEW ISCHEMIC STROKE (BILATERAL A2 OCCLUSIONS) WERE NOTED ON THE PROCEDURAL ANGIOGRAMS. THE 24 HOUR POST PROCEDURE IMAGING SHOWED EVIDENCE OF INTRACRANIAL HEMORRHAGE, HEMORRHAGE INFARCTION TYPE 2 (ICH, HI-2). THE COMMITTEE REVIEWED AND ADJUDICATED THE VASOSPASM, ISCHEMIC STROKE AND INTRACRANIAL HEMORRHAGE. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT, POSSIBLY RELATED TO THE PENUMBRA SYSTEM, PROBABLY RELATED TO THE ANGIOGRAPHIC PROCEDURE AND UNRELATED TO THE INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IVTPA) AND THE INDEX STROKE. THE NEW ISCHEMIC STROKE WAS ADJUDICATED TO BE A SERIOUS

  Patient problems: Intracranial Hemorrhage; Ischemia; Vasoconstriction

  MAUDE report 5141232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072718. One submission often covers many models, so check the product and lot details in each record.

• Z-0428-2011 · Oct 25, 2010 · Terminated
  Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.