Penumbra Coil 400 4004J15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M4244004J150), received between Sep 25, 2015 and May 10, 2019 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, IT WAS REPORTED THAT THREE PC400S DID NOT TAKE THEIR INTENDED SHAPE AND, THEREFORE, THE PC400S WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW PC400S AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599816 ↗
• MalfunctionMay 19, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S). IT WAS NOTED THAT THE PATIENT HAD A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 (F65128) INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ATTEMPTED TO DETACH THE PC400 USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE); HOWEVER, THE PC400 FAILED TO DETACH. IT WAS NOTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE PUSHER ASSEMBLY ONLY SHOWED A SMALL GAP OF 0.5 CM. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE PX SLIM; HOWEVER, IT DID NOT IMPROVE THE SITUATION; THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE PC400. UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM AND THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED PC400 INTO THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED THE SECOND PC400 (F67056) INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN ENCOUNTERED THE SAME DIFFICULTY WHILE ATTEMPTING TO DETACH THE PC400 USING THE SAME HANDLE. REPOSITIONING THE PX SLIM DID NOT HELP. THE PC400 WAS THEN MANUALLY DETACHED IN THE ANEURYSM. IT WAS REPORTED THAT WHEN MANUALLY DETACHING THIS PC400, RESISTANCE WAS E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6579955 ↗
• MalfunctionDec 15, 2016Detachment Of Device Component; Detachment Of Device Component

  DESPITE SEVERAL ATTEMPTS MADE FOR ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, CLARIFICATION WAS NOT PROVIDED UNTIL JANUARY 9, 2017 WHICH STATED THAT THERE WAS A MIX UP OF CASES AND DEVICES WHEN PROVIDING THE DESCRIPTION OF THE EVENT, AND THAT THIS PARTICULAR DEVICE (LOT # F64398) DID NOT UNINTENTIONALLY DETACH. THE TRUE COMPLAINT AGAINST THIS DEVICE IS THAT THERE WAS RESISTANCE NOTED WHILE ATTEMPTING TO ADVANCE THE COIL AND WAS THEREFORE REMOVED. BASED ON THE CLARIFICATION PROVIDED, THE INCIDENT DESCRIPTION HAS NOW BEEN CORRECTED AS FOLLOWS: THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A RECURRENT ANEURYSM USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE PC400 INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM); THEREFORE THE PC400 WAS REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE USING THE SAME PX SLIM AND A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6177157 ↗
• MalfunctionDec 23, 2015Failure to Advance; Physical Resistance; Difficult to Advance

  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 5324693 ↗
• 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 5114254 ↗
• MalfunctionSep 25, 2015Device Operational Issue

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400 COIL) AND A RUBY COIL. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE PC400 COIL THROUGH A PX SLIM AND REMOVED IT. AFTER SUCCESSFULLY DEPLOYING A NEW PC400 COIL INTO THE ANEURYSM IT FAILED TO COIL IN THE PROPER MANNER AND WAS REMOVED FROM THE PATIENT. DURING THE THIRD ATTEMPT THE PHYSICIAN USED A RUBY COIL WHICH BENT UPON ADVANCING IT THOUGH A PX SLIM. THE RUBY COIL WAS REMOVED AND WAS NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW RUBY COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5105116 ↗