Penumbra Coil 400 4006C0305Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M4244006C03050), received between Oct 30, 2015 and Feb 26, 2018 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEEDING ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY (PCOMM), USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE PC400S IN THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING AND WITHDRAWING ANOTHER PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM; HOWEVER, THE PHYSICIAN WAS ABLE TO PUSH AND SUCCESSFULLY PLACE THE DETACHED PC400 IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER PC400 IN THE TARGET VESSEL. HOWEVER, WHILE ADVANCING AND WITHDRAWING THE PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. WHEN ATTEMPTING TO MANEUVER THE DETACHED PC400, THE PUSHER ASSEMBLY OF THE PC400 PERFORATED THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED WITH THE DETACHED PC400 AND THE PUSHER ASSEMBLY INSIDE, AS THE PHYSICIAN ASPIRATED THROUGH THE PX SLIM. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE PHYSICIAN NEEDED TO APPLY FORCE WHILE PLACING THE PC4

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298093 ↗
• InjuryOct 30, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). IT WAS NOTED THAT THE CERVICAL PORTION OF THE DOMINANT RIGHT VERTEBRAL ARTERY WAS SEVERELY TORTUOUS, ESPECIALLY IN THE V2 SEGMENT AT THE C4-C6 LEVEL. IN ADDITION, THE CERVICAL PORTION OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WAS MILDLY TORTUOUS AND NON-FLOW-LIMITING STENOSIS WAS VISUALIZED AT THE ORIGIN OF THE RIGHT EXTERNAL CAROTID ARTERY (ECA). DURING THE PROCEDURE, FOUR PC400 COILS WERE DELIVERED INTO THE ANEURYSM FOLLOWING PLACEMENT OF ANOTHER MANUFACTURERS' DEVICES. AFTER PLACEMENT OF THE OTHER MANUFACTURER'S DEVICE, THERE WAS NO EVIDENCE OF PARENT VESSEL INJURY, ARTERIAL DISSECTION OR DISTAL EMBOLIC EVENTS. HOWEVER, UPON REMOVAL OF THE GUIDE CATHETER, IMAGING OF THE RIGHT CERVICAL ARTERY SHOWED AN IATROGENIC DISSECTION WITHIN THE MID V2 SEGMENT AT THE LOCATION OF THE SEVERE TORTUOSITY. THE PHYSICIAN ADDRESSED THE DISSECTION BY USING ANOTHER MANUFACTURER'S DEVICE. ON POST-OPERATIVE DAY 2, THE PATIENT WAS CLINICALLY STABLE AND DISCHARGED TO AN EXTENDED CARE FACILITY. THE INVESTIGATOR ADJUDICATED THE DISSECTION TO BE OF UNCERTAIN RELATIONSHIP TO THE PC400

  Patient problems: Vascular Dissection

  MAUDE report 5193023 ↗