Penumbra Coil 400 4002C0310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244002C03100), received between Feb 25, 2016 and Mar 21, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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.

• MalfunctionMar 21, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) FOR A TYPE II ENDOLEAK REPAIR USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO PC400 COILS THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN MET RESISTANCE AROUND THE HUB OF THE MICROCATHETER AND WAS UNABLE TO ADVANCE THE COILS. THE TWO PC400 COILS AND THE MICROCATHETER WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S COILS AND ANOTHER MANUFACTURER'S MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5515134 ↗
• MalfunctionMar 21, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) FOR A TYPE II ENDOLEAK REPAIR USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO PC400 COILS THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN MET RESISTANCE AROUND THE HUB OF THE MICROCATHETER AND WAS UNABLE TO ADVANCE THE COILS. THE TWO PC400 COILS AND THE MICROCATHETER WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S COILS AND ANOTHER MANUFACTURER'S MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5515126 ↗
• MalfunctionFeb 25, 2016Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ADVANCING THE TWENTY-FOURTH PC400 COIL THROUGH THE PX SLIM, THE PC400 COIL BECAME STUCK INSIDE THE PX SLIM. WHILE THE COIL WAS BEING RETRACTED, IT STARTED TO UNRAVEL INSIDE THE PX SLIM. THE PHYSICIAN REMOVED BOTH THE PC400 COIL AND THE PX SLIM FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS TIME SINCE THE ANGIOGRAPHY SHOWED THAT THE TARGET VESSEL WAS OCCLUDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5461753 ↗