CERENOVUS ENTERPRISE ENF451400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704071747), received between Aug 6, 2024 and Jun 9, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, A 147MML WNO DSTL TP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC451400, 9540631) WAS IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31352683) AND COULD NOT ADVANCE ANY MORE. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER (MC) AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-MAY-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166281 ↗
• MalfunctionMay 27, 2025Fracture; Failure to Advance; Fracture; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC451400, 9477846) BECAME IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO THE PROWER SELECT PIUS MICROCATHETER (606S255X, LOT UNKNOWN). THE DOCTOR ONLY RETRACTED THE STENT ALONE AND FOUND THE PART WHERE THE STENT AND DELIVERY WIRE CONNECTED BROKE (NOT COMPLETELY DETACHED). THE DOCTOR SWITCHED TO NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-MAY-2025 INDICATED THAT NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE DEVICE FROM THE PATIENT. THE DISTAL TIP OF THE ENTERPRISE WAS NOT RE-SHAPED PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WAS NO PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090212 ↗
• MalfunctionApr 29, 2025Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, PRIOR TO USE, THE DOCTOR OPENED THE DEVICE PACKAGING OF A 4.5MMD 14MML ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC451400, 9061875) AND REMOVED THE DEVICE FROM DISPENSER HOOP. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-APR-2025 INDICATED THAT THERE WAS NO PHYSICAL DAMAGE NOTED ON THE STENT/STENT DELIVERY SYSTEM. THE REPLACEMENT STENT WAS ANOTHER 4.5MMD 14MML ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE. THE EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925800 ↗
• MalfunctionMar 17, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION TO THE POSTERIOR COMMUNICATING SEGMENT OF INTERNAL CAROTID ARTERY, A 4.5MMD 14MML ENTERPRISE INTRACRANIAL STENT (ENC451400, 8779771) BECAME IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER (MC). THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE INTRODUCER. THE DOCTOR REMOVED THE INTRODUCER AND DELIVERY WIRE AS A WHOLE. A NEW STENT WAS USED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-MAR-2025 INDICATED THAT THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. IT WAS NOTED THAT THE ENTERPRISE APPEARED DAMAGE PRIOR TO INFUSION INTO THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619655 ↗
• MalfunctionMar 11, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 14MML ENTERPRISE INTRACRANIAL STENT (ENC451400, 8697626) BECAME IMPEDED IN THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31247199) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A SECOND STENT, A 4.5MMD 14MML ENTERPRISE INTRACRANIAL STENT (ENC451400, 8994883) AND A NEW PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31093248). HOWEVER, THE SECOND STENT ALSO BECAME IMPEDED IN THE MICROCATHETER, IT COULD NOT PASS THROUGH THE SECOND MICROCATHETER. THE DOCTOR REMOVED THE SECOND STENT AND THE SECOND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574779 ↗
• MalfunctionMar 11, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 14MML ENTERPRISE INTRACRANIAL STENT (ENC451400, 8697626) BECAME IMPEDED IN THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31247199) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A SECOND STENT, A 4.5MMD 14MML ENTERPRISE INTRACRANIAL STENT (ENC451400, 8994883) AND A NEW PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31093248). HOWEVER, THE SECOND STENT ALSO BECAME IMPEDED IN THE MICROCATHETER, IT COULD NOT PASS THROUGH THE SECOND MICROCATHETER. THE DOCTOR REMOVED THE SECOND STENT AND THE SECOND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573529 ↗
• MalfunctionMar 5, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 14MML ENTERPRISE INTRACRANIAL STENT WITH NOR DISTAL TIP (ENC451400, 8697555) BECAME IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER (MC). THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN INTRODUCER. THE DOCTOR REMOVED THE INTRODUCER AND DELIVERY WIRE AS A WHOLE. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-MAR-2025 INDICATED THAT THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. A CONTINUOUS FLUSH WAS MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526562 ↗
• MalfunctionAug 6, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 14MML WNO DSTL TP INTRACRANIAL STENT (ENC451400, 8907858) BECAME IMPEDED IN PROXIMAL OF A SL-10® MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE MICROCATHETER AND STENT FROM PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED ADDITIONAL EVENT INFORMATION RECEIVED ON 06-AUG-2024 INDICTED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. OTHER DEVICES WERE SUCCESSFULLY USED WITH THE CONCOMITANT DEVICE AFTER THE ENCOUNTERED RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918762 ↗