Penumbra Coil 400 4004C0412Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244004C04120), received between Apr 20, 2016 and Jan 12, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN ORIGIN OF THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PC400 AND REPORTED THAT THE COIL UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 AND FLUSHED THE COIL OUT OF THE PX SLIM USING A THREE ML SYRINGE. THE PHYSICIAN THEN RE-INTRODUCED THE SAME PX SLIM INTO THE TARGET LOCATION AND ATTEMPTED TO IMPLANT ANOTHER PC400. WHILE RETRACTING THE PC400 FOR RE-POSITIONING, THE PCOM DISSECTED CAUSING THROMBOSIS OF THE ANEURYSM AND PART OF THE PCOM. THEREFORE, THE PC400 WAS REMOVED INTACT. THE PHYSICIAN THEN ADMINISTERED AN ANTIPLATELET DRUG. THE PROCEDURE WAS ENDED AT THIS POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509138 ↗
• MalfunctionFeb 10, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A NEURON 6F 070 DELIVERY CATHETER (NEURON 070). DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE NEURON MAX INTO THE PATIENT. THE PHYSICIAN THEN ADVANCED THE NEURON 070 AND THE PX SLIM THROUGH THE NEURON MAX AND SUCCESSFULLY IMPLANTED TWO PC400S INTO THE TARGET VESSEL. WHILE ADVANCING A THIRD PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO PULL THE PC400 BACK. HOWEVER, UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED AND BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358401 ↗
• MalfunctionDec 21, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 INTO A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 WOULD NOT ADVANCE PAST THE PROXIMAL END OF THE PX SLIM; 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 Consequences Or Impact To Patient

  MAUDE report 8189953 ↗
• 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) 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 7707502 ↗
• MalfunctionApr 20, 2016Stretched; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400) AND A STRAIGHT PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, AFTER SUCCESSFULLY DELIVERING ONE PC400, THE PHYSICIAN ADVANCED A NEW PC400 AND IT BECAME STRETCHED. THE PHYSICIAN REPORTED FEELING NO RESISTANCE PRIOR TO THIS DAMAGE. THE PX SLIM AND STRETCHED PC400 WERE REMOVED FROM THE PATIENT. ALTHOUGH THE PC400 WAS STRETCHED, THERE WAS NO ISSUE REPORTED WITH THE PX SLIM DEVICE. HOWEVER, THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE USING A 90 DEGREE PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5588036 ↗