Penumbra Coil 400 4004C0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M4244004C03060), received between Dec 28, 2015 and May 17, 2021 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA COIL 400 (PC400), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, A PC400 WOULD NOT ADVANCE INTO THE MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS, THE SAME MICROCATHETER, THE SAME CATHETER AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837527 ↗
• MalfunctionMar 10, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA USING PENUMBRA COILS 400 (PC400¿S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INITIAL PC400S THROUGH A PX SLIM WITHOUT A ROTATING HEMOSTASIS VALVE (RHV) AND CONTINUOUS FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND PC400S WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE NEW PC400S; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400S WOULD NOT ADVANCE THROUGH THE NEW PX SLIM. THEREFORE, THE PC400S WERE REMOVED. IT WAS REPORTED THAT AFTER CONNECTING THE PX SLIM WITH A RHV, A FLUSH LINE AND HOLDING THE HUB OF THE PX SLIM STRAIGHT, THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6395027 ↗
• InjuryFeb 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUCCESSFULLY UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COILS 400 (PC400 COILS). SIX MONTHS POST-PROCEDURE THE PATIENT EXPERIENCED TRANSIENT NEUROLOGIC DEFICIT AND WAS TREATED WITH PLAVIX. A MAGNETIC RESONANCE IMAGING/ANGIOGRAPHY (MRI/MRA) CONFIRMED THAT THIS SERIOUS ADVERSE EFFECT (TRANSIENT NEUROLOGIC DEFICIT) WAS RESOLVED. THIS SERIOUS ADVERSE EFFECT WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS, AND AN UNRELATED RELATIONSHIP TO BOTH THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM/MALFORMATION DISEASE STATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 5458669 ↗
• InjuryDec 28, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR BASILAR ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE PC400 COILS INTO THE ANEURYSM WITH NO IMMEDIATE COMPLICATIONS. HOWEVER, AFTER THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED MODERATE HYDROCEPHALUS. A VENTRICULOSTOMY WAS PERFORMED AND THE EVENT WAS RESOLVED ON (B)(6) 2012. THE REPORTED MODERATE HYDROCEPHALUS WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH POSSIBLE RELATIONSHIP TO THE PC400 COILS, PROBABLE RELATIONSHIP TO ANGIOGRAPHIC PROCEDURE AND DEFINITE RELATIONSHIP TO THE ANEURYSM STATE.

  Patient problems: Hydrocephalus

  MAUDE report 5331282 ↗