Penumbra Coil 400 4002C0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244002C05100), received between Dec 28, 2015 and Jul 20, 2018 — 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 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURE ANEURYSM USING PENUMBRA COILS 400 (PC400S) WITH NO ISSUES. THE NEXT DAY, THE PATIENT HEALTH STATUS DECLINED. A COMPUTERIZED TOMOGRAPHY/COMPUTERIZED TOMOGRAPHY ANGIOGRAM (CT/CTA) THEN MAGNETIC RESONANCE IMAGING (MRI) WERE ORDERED. THE PATIENT REMAINS WEAK ON RIGHT SIDE AND SOMNOLENT. ACCORDING TO THE PHYSICIAN, THE MRI WITH LEFT SIDE INFRACT THAT APPEARED MORE WATERSHED. THE CTA WAS CLEAR BEYOND THE COIL MASS. THE MAGNETIC RESONANCE ANGIOGRAPHY (MRA) SHOWED SOME NARROWING NEAR THE COIL MASS WHICH IS PARTIALLY ARTIFACT BUT OVERALL LOOKS PATENT. THE PATIENT IS ALREADY ON ACETYLSALICYLIC ACID (ASA) AND HAD HEPARIN DURING CASE. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2018. AS OF 03-JUL-2018, THE EVENT WAS STILL CONSIDERED UNRESOLVED. THE LEFT CEREBRAL WATERSHED STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE PC400 SYSTEM AND THE PROCEDURE.

  Patient problems: Ischemia; Lethargy; Weakness

  MAUDE report 7707633 ↗
• 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 5823660 ↗
• MalfunctionDec 28, 2015Detachment Of Device Component

  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, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 COIL (LOT # F40411) THROUGH THE PX SLIM. THE PC400 COIL WAS REMOVED AND A NEW PC400 COIL (LOT # F42601) WAS USED. HOWEVER, THIS SECOND PC400 COIL UNINTENTIONALLY DETACHED AND BECAME STUCK IN THE PX SLIM. THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 COIL FROM THE PATIENT. THE PROCEDURE CONTINUED USING A NEW PC400 COIL AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5331365 ↗