CERENOVUS ENTERPRISE ENF451412Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704044017), received between Oct 15, 2024 and Sep 10, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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.

• MalfunctionSep 10, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X14MM 12MM DW TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC451412, 8997141) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE. IT WAS FOUND THAT 2 DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED OR EXPANDED AS INTENDED. THE DOCTOR REMOVED THE STENT AND THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) FROM THE PATIENT AND FOUND THE STENT BODY WAS KINKED/BENT. THEN THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY WITH THE ORIGINAL MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-SEP-2025 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO SIGNIFICANT RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT APPEARED DAMAGED, KINKING AT THE TIP. IT WAS NOTED THAT THE VESSEL WAS TORTUOUS. THE STENT WAS TRIED TO ¿TWIST¿ IN THE ATTEMPT TO EXPAND THE STENT. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. THERE WAS NO BLOOD FLOW RESTRICTION. THE PROCEDURE WAS NOT DELAYED/PROLONGED DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017058 ↗
• MalfunctionAug 25, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5 X 14 MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC451412, 8878735) WAS IMPEDED IN THE HUB OF A NON-J&J MICROCATHETER. 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-AUG-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE SIZE AND BRAND OF THE MICROCATHETER WAS NOT AVAILABLE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885371 ↗
• InjuryAug 14, 2025Activation Failure; Activation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EU 4.5X14MM STENT 12 MM DW TIP (ENC451412/ 9123410) AND PROWLER SELECT PLUS 150/5CM (606S255X/ LOT # UNKNOWN) WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED INCOMPLETE EXPANSION OF THE ENTERPRISE STENT. WHEN THE STENT WAS PLACED AND RELEASED AT THE TARGET SITE, IT WAS FOUND THAT THE DISTAL MARKERS EXPANDED FULLY, BUT THE PROXIMAL MARKERS WERE CONVERGED. IT WAS ALSO FOUND THAT THE PARENT VESSEL WAS OCCLUDED. THE PHYSICIAN REMOVED THE PROWLER MICROCATHETER FROM THE PATIENT AND USED A BALLOON CATHETER (OTHER BRAND) FOR DILATION, AND THE BLOOD FLOW OF THE PARENT VESSEL WAS RESTORED. SINCE THE PROXIMAL MARKERS OF THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED, THE PHYSICIAN DELIVERED A SECOND STENT USING THE ORIGINAL MICROCATHETER AND RELEASED THE SECOND STENT IN THE FIRST STENT AND COMPLETED THE SURGERY. THE PROCEDURE WAS PROLONGED BY ABOUT 30 MINUTES. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 13-AUG-2025. SUMMARY: THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH AND IT WAS FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING THE ADVA

  Patient problems: Obstruction/Occlusion

  MAUDE report 22806518 ↗
• MalfunctionAug 6, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X14MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC451412, 9493883) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31469833) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-JUL-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 PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730851 ↗
• MalfunctionJul 15, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION, AFTER AN UNSPECIFIED MICROCATHETER WAS IN PLACE, A 4.5X14MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC451412, 8878735) WAS IMPEDED IN PROXIMAL END OF THE MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF THE Y CONNECTOR. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509838 ↗
• MalfunctionJun 17, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X14MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC451412, 9123410) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31471118) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JUN-2025 INDICATED THAT 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 22236689 ↗
• MalfunctionJan 30, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X14MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC451412, 8337174) BECAME IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, UNKNOWN LOT) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR TRIED TO ONLY RETRACT THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A NEW STENT AFTER REMOVING THE FIRST STENT TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274311 ↗
• MalfunctionOct 15, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X14MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC451412, 7682978) BECAME IMPEDED IN Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT AND IT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER (MC) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-OCT-2024 INDICATED THAT 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 A 3-MINUTE PROCEDURAL DELAY DUE TO THE EVENT, BUT IT WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449584 ↗