Penumbra System PSC026Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548010304), received between Dec 28, 2018 and Dec 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 28, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 026 (CATHETER 026). DURING THE PROCEDURE, WHILE ADVANCING THE CATHETER 026 THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE CATHETER 026 BROKE APPROXIMATELY FIVE CENTIMETERS FROM ITS HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER 026 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8203112 ↗

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.