Penumbra System PSF026Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548010403), received between Jul 12, 2017 and Mar 16, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2018Break; Physical Resistance; Break; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 026 (CATHETER 026) AND A PENUMBRA SYSTEM 026 SEPARATOR FLEX (SEPARATOR 026 FLEX). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA SHEATH AND CATHETER TOWARD THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A CATHETER 026 THROUGH THE CATHETER. WHILE INITIALLY ADVANCING A SEPARATOR 026 FLEX THROUGH THE CATHETER 026, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER COMPLETION OF A PASS, THE PHYSICIAN PULLED THE SEPARATOR 026 FLEX INTO THE CATHETER 026; HOWEVER, THE SEPARATOR 026 FLEX BROKE INSIDE THE CATHETER 026. THEREFORE, THE PHYSICIAN REMOVED CATHETER 026 CONTAINING THE BROKEN SEPARATOR 026 FLEX. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH, CATHETER AND A STENT RETRIEVER DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7345398 ↗
• MalfunctionNov 15, 2017Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  WHILE PREPARING A PENUMBRA SYSTEM 026 SEPARATOR FLEX (SEPARATOR 026 FLEX) ON THE BACK TABLE FOR A THROMBECTOMY PROCEDURE, THE TIP OF THE SEPARATOR 026 FLEX BROKE OFF. IT WAS REPORTED THAT THE SEPARATOR 026 FLEX WAS BEING PREPPED THROUGH A PENUMBRA SYSTEM REPERFUSION CATHETER 026 (CATHETER 026) AND THAT NOTHING OUT OF THE ORDINARY WAS NOTICED. THE TIP OF THE SEPARATOR 026 FLEX BROKE PRIOR TO USE AND THEREFORE, THE SEPARATOR 026 FLEX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW SEPARATOR 026 FLEX AND THE SAME CATHETER 026.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7033963 ↗
• MalfunctionJul 12, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM 026 SEPARATOR FLEX (SEPARATOR 026 FLEX) WAS KINKED. THE KINKED SEPARATOR 026 FLEX WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SEPARATOR 026 FLEX.

  Patient problems: No Patient Involvement

  MAUDE report 6709093 ↗