CERENOVUS ENTERPRISE ENF453700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704071808), received between Mar 4, 2025 and Oct 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Premature Activation; Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO USE, THE DOCTOR OPENED DEVICE PACKAGING OF A 4.5MMD 37MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC453700, 9477855) AND REMOVED THE DEVICE FROM DISPENSER HOOP. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-OCT-2025 INDICATED THAT BESIDES THE REPORTED PREMATURE DETACHMENT, THERE WAS NO PHYSICAL DAMAGE NOTED ON THE STENT/STENT DELIVERY SYSTEM APPEAR DAMAGED. THE REPLACEMENT STENT WAS NOT ANOTHER ENTERPRISE2 4.5MMD 37MML 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 23280170 ↗
• MalfunctionMay 27, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 37MML WNO DSTL TP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC453700/9208255) WAS IMPEDED IN A CERENOVUS MICROCATHETER HUB AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT ALONE AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER HUB. THE PHYSICIAN USED THE OTHER DEVICE TO REMOVE THE STENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE. THE MICROCATHETER (MC) WAS NOT REPLACED. NO PATIENT INJURIES NOR CONSEQUENCES WERE REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-MAY-2025 INDICATED THAT NO TORQUEING DEVICE WAS USED; THEREFORE, THEY COULD NOT TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. A CERENOVUS MICROCATHETER WAS USED, AND THE MICROCATHETER WAS NOT KINKED/BENT. NO EXCESSIVE FORCE WAS USED WITH THE DEVICES. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY/PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090386 ↗
• MalfunctionMar 4, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 37MML WNO DSTL TP INTRACRANIAL STENT (ENC453700, 9208255) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31471106) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR TRIED TO RETRACT THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-MAR-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. THE PROCEDURE WAS DELAYED BY 10 MINUTES, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514812 ↗