Penumbra Coil 400 4006U0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244006U02030), received between Oct 30, 2015 and Apr 16, 2021 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionApr 16, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PAC400) AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PAC400 WOULD NOT DEPLOY. THEREFORE, IT WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681897 ↗
• MalfunctionOct 11, 2016Retraction Problem; Inadequacy of Device Shape and/or Size; Mechanical Jam; Retraction Problem; Inadequacy of Device Shape and/or Size; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400''S (PC400'S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO RETRACT THE PC400 DUE TO INCORRECT SIZING; HOWEVER, UPON RETRACTION, THE PC400 BECAME STUCK IN THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM TO REMOVE THE STUCK PC400 AND NOTICED THAT THE TIP OF THE PX SLIM HAD AN ACCORDION-LIKE COMPRESSION DAMAGE. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND ADDITIONAL PC400S. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6019354 ↗
• MalfunctionMar 31, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, A PC400 COIL WAS UNABLE TO ADVANCE THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND THE PC400 COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL WITH 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 5538697 ↗
• 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 5193110 ↗
• 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 5193105 ↗