Penumbra Coil 400 400PAC60Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948021358), received between Jun 15, 2021 and Jul 25, 2025 — 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.

• MalfunctionJul 25, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE FOR A CAROTID ARTERY DISSECTION USING PAC400 COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PAC400 TO THE TARGET LOCATION, THE PAC400 UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE DETACHED COIL WAS PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE CAROTID ARTERY. THE COIL PUSHER ASSEMBLY WAS USED TO PUSH THE REST OF THE PAC400 COIL OUT OF THE PX SLIM INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED WITH MORE PAC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22616618 ↗
• MalfunctionJan 24, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PAC400 COIL, A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE PAC400 INTO THE TARGET LOCATION USING THE HANDLE. WHILE ADVANCING A SECOND PAC400 COIL TO THE TARGET LOCATION, THE SECOND PAC400 UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE DETACHED PAC400. THE PROCEDURE WAS COMPLETED USING A THIRD PAC400, THE SAME HANDLE, AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233066 ↗
• MalfunctionJun 15, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE IN THE AORTIC ARCH USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PC400 WOULD NOT FULLY ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005240 ↗