Penumbra Coil 400 4004C1235Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244004C12350), received between Jan 30, 2017 and Jul 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PC400 USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND NEURON 6F 070 DELIVERY CATHETER (NEURON 070). WHILE ATTEMPTING TO ADVANCE A NEW PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PC400. THE PROCEDURE WAS COMPLETED USING A NEW PC400, THE SAME NEURON 070 AND SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780550 ↗
• MalfunctionJan 30, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM); THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM, NINE NEW PC400'S, AND NON-PENUMBRA COILS. IT SHOULD BE NOTED THAT THE PHYSICIAN REPORTED USING A ROTATING HEMOSTASIS VALVE AND MAINTAINING CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6287859 ↗