Penumbra Coil 400 4004C0406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M4244004C04060), received between Jan 26, 2016 and Nov 15, 2017 — classified as 1 injury, 2 malfunctions.

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.

• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400'S) WITH NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ON (B)(6) 2017, THE PATIENT PRESENTED AT THE HOSPITAL WITH A RIGHT ARM AND LEG SENSATION CHANGE. THE RIGHT ARM SENSATION RESOLVED SPONTANEOUSLY; HOWEVER, THE PATIENT HAD DECREASED SENSATION BELOW THE KNEE AND A COLD FEELING WAS PRESENT. THE PATIENT'S NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE AT BASELINE WAS A 3. THE RESULTS OF THE COMPUTERIZED TOMOGRAPHY (CT) HEAD AND COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE NEGATIVE AT BASELINE. THE PATIENT WAS GIVEN INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV-TPA) AND THE SYMPTOMS RESOLVED ON (B)(6) 2017. THE REPORTED FOCAL NEUROLOGICAL DEFICIT WAS ADJUDICATED TO BE AN ADVERSE EVENT THAT WAS POSSIBLY RELATED TO THE PC400 BUT UNRELATED TO THE PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7033491 ↗
• MalfunctionJun 23, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN DELIVERED TWO PC400 COILS IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ADVANCED A NEW PC400 THROUGH THE PX SLIM; HOWEVER, WHILE ATTEMPTING TO RETRACT THE PC400, IN ORDER TO PROPERLY DEPLOY IT IN THE ANEURYSM, IT UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN DID NOT EXPERIENCE ANY UNDUE RESISTANCE WHILE RETRACTING THE PC400 THROUGH THE PX SLIM. THE DETACHED PC400 WAS REMOVED FROM THE PX SLIM AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 WITH THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5745110 ↗
• MalfunctionJan 26, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PC400 COIL INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PC400 COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING TWELVE NEW PC400 COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5391876 ↗