Penumbra Coil 400 4006C0308-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548018195), received between Nov 4, 2019 and Nov 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE WITH STENT ASSIST IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, A NON-PENUMBRA STENT WAS PLACED ACROSS THE ANEURYSM, FOLLOW BY THE PX SLIM AND A NON-PENUMBRA MICROCATHETER, WHICH WERE ADVANCED THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO PC400S IN THE ANEURYSM USING THE PX SLIM. WHILE ADVANCING THE NEXT PC400 THROUGH THE PX SLIM IN THE ANEURYSM, IT WAS NOTICED THAT THE PC400 WAS TOO LONG; THE PHYSICIAN EXPERIENCED RESISTANCE AND PART OF THE PC400 BEGAN FALLING OUT OF THE ANEURYSM AND DOWN INTO THE PARENT VESSEL. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO PARTIALLY RETRACT THE PX SLIM TO REMOVE THE PC400. UPON REMOVAL OF THE PC400, THE PHYSICIAN NOTICED IT WAS STRETCHED WITH THE COIL WINDS VISIBLE. NEXT, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL MARKER ON THE PX SLIM WAS LOCATED OUTSIDE THE ANEURYSM; THEREFORE, THE PHYSICIAN CONTINUED RETRACTING THE PX SLIM OUT FROM BETWEEN THE STENT AND THE TARGET VESSEL AND ATTEMPTED TO RECANNULATE THE ANEURYSM THROUGH THE STENT, B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9275957 ↗