Penumbra Coil 400 4002C0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244002C03060), received between Sep 25, 2015 and Jul 26, 2016 — classified as 2 injuries, 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 16, 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.

• InjuryJul 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (ICA-PCOM) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, AFTER EIGHT PC400 COILS WERE DEPLOYED AND DETACHED IN THE ANEURYSM, MINIMAL THROMBUS FORMATION WAS NOTED AT THE ANEURYSM NECK. THEREFORE, THE PATIENT WAS ADMINISTERED FOUR THOUSAND UNITS OF HEPARIN AND SUBSEQUENTLY, THE THROMBUS RESOLVED. THE REPORTED MINIMAL THROMBUS FORMATION WAS ADJUDICATED TO HAVE A DEFINITE RELATIONSHIP TO THE PC400 COIL SYSTEM, AN UNRELATED RELATIONSHIP TO THE PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE DISEASE STATE.

  Patient problems: Thrombus

  MAUDE report 5823768 ↗
• InjuryJul 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (ICA㐃OM) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, AFTER EIGHT PC400 COILS WERE DEPLOYED AND DETACHED IN THE ANEURYSM, MINIMAL THROMBUS FORMATION WAS NOTED AT THE ANEURYSM NECK. THEREFORE, THE PATIENT WAS ADMINISTERED FOUR THOUSAND UNITS OF HEPARIN AND SUBSEQUENTLY, THE THROMBUS RESOLVED. THE REPORTED MINIMAL THROMBUS FORMATION WAS ADJUDICATED TO HAVE A DEFINITE RELATIONSHIP TO THE PC400 COIL SYSTEM, AN UNRELATED RELATIONSHIP TO THE PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE DISEASE STATE.

  Patient problems: Thrombus

  MAUDE report 5823741 ↗
• MalfunctionSep 25, 2015Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY DETACHING A PC400 COIL INTO THE ANEURYSM, BUT IT DID EVENTUALLY DETACH. HOWEVER, TWO NEW PC400 COILS FAILED TO DETACH AND WERE SUCCESSFULLY REMOVED. THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5105561 ↗