Penumbra Coil 400 4002C0715Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244002C07150), received between Sep 30, 2015 and Jul 26, 2016 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 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 5823630 ↗
• MalfunctionMay 6, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 UNINTENTIONALLY DETACHED WITH PART OF THE COIL REMAINING INSIDE OF THE PX SLIM AND THE OTHER PART OF THE COIL OUTSIDE OF THE PX SLIM. IN AN ATTEMPT TO PUSH THE DETACHED PC400 OUT OF THE PX SLIM COMPLETELY AND INTO THE TARGET VESSEL, THE PHYSICIAN ADVANCED A NEW PC400 THROUGH THE PX SLIM; HOWEVER, THE NEW PC400 DETACHED AS WELL. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE TWO DETACHED PC400 COILS IN THE TARGET VESSEL BY USING A NEW PC400; HOWEVER, THE NEW PC400 DETACHED WHILE BEING ADVANCED THROUGH THE PX SLIM. THE SAME SCENARIO HAPPENED WITH A NEW (FOURTH) PC400. FINALLY, THE PHYSICIAN SUCCESSFULLY PUSHED ALL FOUR DETACHED PC400 COILS OUT OF THE PX SLIM AND INTO THE TARGET VESSEL USING A NEW PC400. THE PROCEDURE WAS COMPLETED USING THAT PC400 AND TWO ADDITIONAL PC400 COILS AND THE SAME PX SLIM USED THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5638072 ↗
• InjurySep 30, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ANTERIOR CEREBRAL ARTERY (ACA)-ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THIRTEEN PC400 COILS WERE SUCCESSFULLY DEPLOYED AND DETACHED INTO THE ANEURYSM WITH NO COMPLICATIONS. APPROXIMATELY 3 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED A SEVERE ISCHEMIC STROKE IN THE LEFT ANTERIOR CEREBRAL ARTERY. CORONARY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA), MAGNETIC RESONANCE IMAGING (MRI), ELECTROENCEPHALOGRAM (EEG), TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE PERFORMED AND THE PATIENT WAS TREATED WITH SIMVASTATIN. THE REPORTED ISCHEMIC STROKE RESOLVED ON (B)(6) 2013.

  Patient problems: Infarction, Cerebral

  MAUDE report 5114223 ↗