Penumbra Coil 400 4006U0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244006U02020), received between Jul 19, 2016 and May 2, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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.

• MalfunctionMay 2, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PC400S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AFTER ADVANCING A NEW PC400 INTO THE VESSEL, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH THE PC400 USING A HANDLE; HOWEVER, IT FAILED TO DETACH. THEREFORE, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO END THE PROCEDURE TO BRING BACK THE PATIENT AT A LATER DATE TO PLACE A NON-PENUMBRA PIPELINE STENT; THEREFORE, NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575483 ↗
• InjuryJul 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE CHOROIDAL SEGMENT OF THE RIGHT SUPRACLINOID INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS). THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. HOWEVER, THE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED TWO EPISODES OF TRANSIENT LEFT-SIDED WEAKNESS. ON (B)(6) 2016, A FOLLOW-UP MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED SMALL INFARCTS SCATTERED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY, WHICH RESOLVED ON THE SAME DAY. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY IN STABLE CONDITION. THE SMALL INFARCTS WERE REPORTED TO BE A TRANSIENT ISCHEMIC ATTACK (TIA) AND A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PC400 COILS, THE ANEURYSM AS WELL AS THE ANGIOGRAPHIC PROCEDURE.

  Patient problems: Transient Ischemic Attack; Weakness

  MAUDE report 5804359 ↗