Penumbra Coil 400 4002C2060-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548019369), received between Jun 8, 2021 and Jun 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT AND RIGHT PELVIC VEINS USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NON-PENUMBRA DIAGNOSTIC CATHETER AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PX SLIM IN THE LEFT PELVIC VEIN. THEN, WHILE ADVANCING APPROXIMATELY TEN CENTIMETERS OF A PC400 THROUGH THE PX SLIM, THE PC400 BECAME STUCK. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE PC400; HOWEVER, RESISTANCE WAS NOTED AND CONSEQUENTLY, THE PC400 REMAINED STUCK WITHIN THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED. NEXT, THE PHYSICIAN PLACED NON-PENUMBRA COILS IN THE TARGET LOCATION USING THE PX SLIM. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY PLACED THE PX SLIM IN THE RIGHT PELVIC VEIN. THEN WHILE THE PHYSICIAN ADVANCED APPROXIMATELY TEN CENTIMETERS OF ANOTHER PC400 THROUGH THE PX SLIM, THE SAME ISSUE OCCURRED. THE PC400 BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962840 ↗
• MalfunctionJun 8, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT AND RIGHT PELVIC VEINS USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NON-PENUMBRA DIAGNOSTIC CATHETER AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PX SLIM IN THE LEFT PELVIC VEIN. THEN, WHILE ADVANCING APPROXIMATELY TEN CENTIMETERS OF A PC400 THROUGH THE PX SLIM, THE PC400 BECAME STUCK. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE PC400; HOWEVER, RESISTANCE WAS NOTED AND CONSEQUENTLY, THE PC400 REMAINED STUCK WITHIN THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED. NEXT, THE PHYSICIAN PLACED NON-PENUMBRA COILS IN THE TARGET LOCATION USING THE PX SLIM. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY PLACED THE PX SLIM IN THE RIGHT PELVIC VEIN. THEN WHILE THE PHYSICIAN ADVANCED APPROXIMATELY TEN CENTIMETERS OF ANOTHER PC400 THROUGH THE PX SLIM, THE SAME ISSUE OCCURRED. THE PC400 BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962138 ↗