Penumbra Coil 400 4002C1348Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244002C13480), received between Aug 28, 2015 and Dec 4, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionDec 4, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE FLUOROSCOPY IMAGING REVEALED THAT THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE MIDDLE OF THE PX SLIM. THE PHYSICIAN ATTEMPTED TO FLUSH THE PC400 OUT OF PX SLIM USING A 3 ML SYRINGE WITHOUT SUCCESS. THEREFORE, THE PX SLIM CONTAINING THE PC400 WAS REMOVED FROM THE PATIENT AND THE COIL WAS SUCCESSFULLY FLUSHED OUT OF THE PX SLIM ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM, ANOTHER PC400, AND A LIQUID EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256594 ↗
• MalfunctionMar 10, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA USING PENUMBRA COILS 400 (PC400¿S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INITIAL PC400S THROUGH A PX SLIM WITHOUT A ROTATING HEMOSTASIS VALVE (RHV) AND CONTINUOUS FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND PC400S WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE NEW PC400S; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400S WOULD NOT ADVANCE THROUGH THE NEW PX SLIM. THEREFORE, THE PC400S WERE REMOVED. IT WAS REPORTED THAT AFTER CONNECTING THE PX SLIM WITH A RHV, A FLUSH LINE AND HOLDING THE HUB OF THE PX SLIM STRAIGHT, THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S 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 6395029 ↗
• MalfunctionSep 2, 2016Positioning Failure; Failure to Advance; Mechanical Jam; Positioning Failure; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A PC400 INTO THE ANEURYSM, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE COIL ONCE IT EXITED THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN WAS ONLY ABLE TO DEPLOY LESS THAN HALF OF THE COIL INTO THE ANEURYSM AND WAS UNABLE TO ADVANCE THE REST OF THE COIL OUT OF THE PX SLIM. THEREFORE, THE PC400 WAS RESHEATHED AND THEN WASHED WITH HEPARIN SALINE. NEXT, THE PHYSICIAN MADE ANOTHER ATTEMPT TO DEPLOY THE PC400 BUT WAS STILL UNABLE TO COMPLETELY ADVANCE THE COIL OUT OF THE PX SLIM. THEREFORE, THE PC400 WAS RETRACTED AND THEN BECAME STUCK IN ITS INTRODUCER SHEATH BEFORE IT WAS FULLY RE-SHEATHED AND REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW PC400'S AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN MAINTAINED A CONTINUOUS FLUSH THROUGH THE PX SLIM AND USED A ROTATING HEMOSTASIS VALVE (RHV) DURING THE PROCEDURE. ADDITIONALLY, EACH COIL WAS ALLOWED TO BACKFLUSH PRIOR TO INSERTION INTO THE PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5925319 ↗
• MalfunctionOct 10, 2015Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400 COIL). DURING THE PROCEDURE, THE PHYSICIAN RESHEATHED THE PC400 COIL AND DEPLOYED IT INTO THE ANEURYSM, HOWEVER, THE PC400 COIL UNINTENTIONALLY DETACHED AND WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE. THE PROCEDURE DID NOT CONTINUE ANY FURTHER. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5142448 ↗
• MalfunctionAug 28, 2015Detachment Of Device Component; Fracture; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400 (PC400) COIL. THE PHYSICIAN ADVANCED THE PX SLIM INTO THE ANEURYSM THROUGH A GUIDE CATHETER, AND PLACED A STENT AT THE NECK OF THE ANEURYSM. THE PC400 COIL WAS REPOSITIONED SEVERAL TIMES DURING DEPLOYMENT INTO THE ANEURYSM. WHILE REPOSITIONING, THE PC400 COIL UNINTENTIONALLY DETACHED PARTIALLY INSIDE THE PX SLIM AND PARTIALLY IN THE ANEURYSM. THE PHYSICIAN CUT THE HUB OF THE PX SLIM AND USED A SNARE DEVICE IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DETACHED PC400 COIL FROM THE PX SLIM. THE PC400 COIL BECAME DAMAGED AND BEGAN TO UNRAVEL. THE PHYSICIAN REMOVED THE PX SLIM AND ATTEMPTED TO ASPIRATE THE DETACHED COIL THROUGH THE GUIDE CATHETER USING A SYRINGE. SYRINGE ASPIRATION WAS UNSUCCESSFUL, AND THE PHYSICIAN WITHDREW THE GUIDE CATHETER FROM THE PATIENT. THE DETACHED PC400 COIL REMAINED PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE PARENT VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 5040336 ↗