Penumbra Coil 400 4006C0410-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548018232), received between Nov 2, 2021 and Oct 3, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID-CAVERNOUS FISTULA (CCF) USING A PENUMBRA COIL 400 (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA CATHETER, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA COIL. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED TRANSVENOUS ACCESS USING THE BMX96 AND NON-PENUMBRA CATHETER. THE PHYSICIAN PLACED A NON-PENUMBRA MICROCATHETER AND PX SLIM SIDE BY SIDE INTO THE DISTAL PORTION OF THE FISTULA AND THEN, ADVANCED A PC400 INTO THE TARGET VESSEL, BUT DETERMINED THE PC400 WAS TOO LARGE FOR THE VESSEL AND WAS REMOVED. NEXT, A SMALLER PC400 WAS ADVANCED INTO THE FISTULA; HOWEVER, THE PHYSICIAN NOTICED THE PC400 WAS ALSO TOO LARGE FOR THE VESSEL AND THE COIL WOULD MOVE BACK INTO THE CAVERNOUS SINUS AND OUT OF THE FISTULA DUE TO THE HIGH FLOW. THE PHYSICIAN PULLED THE ENTIRE PC400 BACK INTO THE PX SLIM WITH THE COIL STILL VISIBLE AT THE TIP OF THE PX SLIM. THE PHYSICIAN THEN ADVANCED THE NON-PENUMBRA COIL THROUGH THE OTHER MICROCATHETER. IT WAS REPORTED THAT THE PX SLIM CONTAINING THE PC400 WAS SUPERIMPOSED ON THE OTHER MICROCATHETER, AND THE PHYSICIAN WAS UNABLE TO VISUA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865906 ↗
• MalfunctionMar 3, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID-CAVERNOUS FISTULA USING A PENUMBRA COIL 400 (PC400), PX SLIM DELIVERY MICROCATHETER (PX SLIM), BENCHMARK BMX96 ACCESS SYSTEM (BMX96), EMBOLIC AGENT, NON-PENUMBRA GUIDE CATHETER, AND A NON-PENUMBRA BALLOON CATHETER. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED TRANSARTERIAL ACCESS ON THE LEFT SIDE USING THE GUIDE CATHETER AND INJECTED THREE VIALS OF EMBOLIC AGENT IN THE FISTULA USING THE BALLOON CATHETER. NEXT, THE PHYSICIAN PLACED THE BMX96 IN THE RIGHT INTERNAL JUGULAR GOING TO THE RIGHT COMMON CAROTID ARTERY AND NOTICED THE INFERIOR PETROSAL SINUS (IPS) WAS NO LONGER VISIBLE DUE TO THE EMBOLIC AGENT CLOSING OFF THE VEIN. THE PHYSICIAN WAS UNABLE TO NAVIGATE AROUND THE TRANSVERSE SINUS USING THE PX SLIM (STRAIGHT) AND GUIDEWIRE; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM (STRAIGHT) AND SWITCH TO A NEW PX SLIM (90). SUBSEQUENTLY, AFTER PULLING BACK ON THE BMX96 AND MAKING MULTIPLE ATTEMPTS TO GO AROUND, THE IPS HAD REOPENED, AND THE PHYSICIAN WAS ABLE TO ACCESS THE CAVERNOUS SINUS USING THE PX SLIM. THE PHYSICIAN THEN ADVANCED THE PC400 INTO THE TARGET LOCATION; HOWEVER, AFTER FORMING APPROXIMAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478847 ↗
• MalfunctionNov 2, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA COILS 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE INSERTING THE PC400 INTO THE RHV, THE PC400 KINKED. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741023 ↗