CERENOVUS ENTERPRISE ENF403912Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886704075394), received between Oct 14, 2016 and Sep 2, 2025 — classified as 1 death, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING ENDOVASCULAR EMBOLIZATION, THE DELIVERY WIRE OF AN ENTERPRISE2 4MMX39MM VASCULAR RECONSTRUCTION DEVICE (ENCR403912, 9320828) PASSED THROUGH MICROCATHETER TIP, BUT THE STENT BODY WAS IMPEDED IN MICROCATHETER TIP AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR ONLY RETRACTED THE STENT ALONE BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF Y CONNECTOR. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-AUG-2025 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER WAS A J&J PRODUCT, HOWEVER, THE BRAND IS NOT AVAILABLE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS NOT PROLONGED OR DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939451 ↗
• MalfunctionAug 11, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX39MM VASCULAR RECONSTRUCTION DEVICE (ENCR403912, 9080740) WAS IMPEDED IN THE DISTAL END A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31527352) AND COULD NOT PASS THROUGH THE MICROCATHETER. 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774524 ↗
• MalfunctionJun 16, 2025Activation Failure; Activation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403912, 8848366) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 11-JUN-2025 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THE STENT DID NOT APPEAR DAMAGED. THERE WAS NO VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. NO ADDITIONAL INTERVENTION WAS PERFORMED TO 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211858 ↗
• MalfunctionMar 14, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX39MM INTRACRANIAL STENT (ENCR403912, 8848349) BECAME IMPEDED IN DISTAL END OF MICROCATHETER (OTHER BRAND) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606946 ↗
• MalfunctionJan 8, 2025Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX39MM INTRACRANIAL STENT (ENCR403912, 8697636) WAS PLACED AT THE TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 07-JAN-2025 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. THERE WAS NO BLOOD FLOW RESTRICTION. THE PROCEDURE WAS PROLONGED BY 5 MINUTES DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103433 ↗
• MalfunctionDec 10, 2024Premature Activation; Product Quality Problem; Premature Activation; Product Quality Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, THE PHYSICIAN WAS UNABLE TO VISUALIZE THE ENTERPRISE2 4MMX39MM INTRACRANIAL STENT (ENCR403912, 8294534) UNDER X-RAY AFTER THE STENT WAS DELIVERED TO THE UNSPECIFIED MICROCATHETER. THE PHYSICIAN ONLY RETRACTED THE STENT AND OBSERVED THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE PREMATURELY. IT WAS UNABLE TO CONFIRM WHEN THE STENT WAS SEPARATED FROM THE DELIVERY WIRE. THE PHYSICIAN SWITCHED A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895528 ↗
• MalfunctionSep 25, 2024Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX39MM INTRACRANIAL STENT (ENCR403912, 8697571) BECAME IMPEDED IN A PROWLER SELECT PLUS 150/5CM MICROCATHETER HUB (606S255X, 31295078) AND COULD NOT ADVANCE ANY MORE. AFTER SEVERAL ATTEMPTS, THE STENT STILL COULD NOT BE PUSHED INTO THE MICROCATHETER (MC). THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT FROM THE PATIENT AND FOUND THAT TIP OF THE STENT WAS KINKED/BENT. NEW DEVICES WERE SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301375 ↗
• MalfunctionSep 3, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY, AN ENTERPRISE 2 4MMX39MM INTRACRANIAL STENT (ENCR403912, 7835934) BECAME IMPEDED IN A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND REPLACED IT WITH A NEW STENT AND USED THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-AUG-2024 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THEY WERE NOT ABLE TO TORQUE THE DEVICE. THE RESISTANCE WAS FELT AT THE SHAFT OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126558 ↗
• MalfunctionMar 23, 2023Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE PHYSICIAN FELT STRONG RESISTANCE DURING THE ADVANCEMENT OF THE COMPLAINT DEVICE, A 4.0MM DIA X 39MM ENTERPRISE®2 STENT (ENF403912 / 7158883) THROUGH THE CONCOMITANT MICROCATHETER, A PHENOM¿ 21 MICROCATHETER (MEDTRONIC). IT WAS THE DISTAL SECTION OF THE MICROCATHETER THEREFORE, THE PHYSICIAN RETRACTED THE STENT AND SAFELY REMOVED IT FROM THE PATIENT¿S BODY. A SECOND ATTEMPT WAS MADE WITH THE SAME MICROCATHETER AND ANOTHER 4.0MM DIA X 39MM ENTERPRISE®2 STENT WAS SUCCESSFUL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION WAS COMPLETED ON 23-MAR-2023. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER TITLE 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16605906 ↗
• MalfunctionMar 20, 2023Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN ENTERPRISE2 4MMX39MM INTRACRANIAL STENT (ENF403912, 6305801) PREMATURELY DEPLOYED INSIDE OF THE Y CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572550 ↗
• MalfunctionOct 5, 2022Retraction Problem; Retraction Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, WHEN A 4.0MM DIA X 39MM ENTERPRISE® 2 STENT (ENF403912 / 6678684) WAS 50% DEPLOYED AND THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT, THE RETRIEVAL WAS NOT SUCCESSFUL. THE PHYSICIAN FELT STRONG RESISTANCE DURING THE RETRIEVAL OF THE STENT INTO THE PROWLER SELECT PLUS MICROCATHETER. THE PHYSICIAN REMOVED ALL DEVICES FROM THE PATIENT¿S BODY AND USED A ¿SAME-LIKE¿ PRODUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547688 ↗
• MalfunctionDec 13, 2021Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, DURING A STENT ASSISTED COIL EMBOLIZATION, A ENTERPRISE2 4MMX39MM INTRACRANIAL NEUROVASCULAR STENT (ENF403912, 6305801) PRE-MATURELY DEPLOYED DURING OPERATION. THE PHYSICIAN USED A SAME-LIKE PRODUCT, HOPEFULLY THE PROCEDURE DONE WELL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984066 ↗
• MalfunctionApr 17, 2018Flushing Problem; Flushing Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE INTRODUCER SHEATH OF THE ENTERPRISE2 (ENF403912/10817885) STENT DELIVERY SYSTEM DID NOT FLUSH PROPERLY. THE INTRODUCER WAS ADVANCED INTO THE ROTATING HEMOSTATIC VALVE (RHV) AND FLUSHED, BUT AIR BUBBLES WERE TRAPPED INSIDE OF THE INTRODUCER SHEATH. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7438604 ↗
• MalfunctionMar 28, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING THE PROCEDURAL, AN ENTERPRISE STENT (ENF403912/ (B)(4)) DID NOT DEPLOY AND FLARE WELL. IT WAS REPORTED THAT THE MICROCATHETER WAS PARTIALLY DEPLOYED OUT OF THE PROWLER SELECT PLUS (CATALOG/LOT UNK) MICROCATHETER. THE SURGEON RECAPTURED IT AND USED ANOTHER PRODUCT TO SUCCESSFULLY COMPLETE THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND THE MICROCATHETER DID NOT APPEAR DAMAGED. NEITHER THE STENT OR STENT DELIVERY SYSTEM APPEARED DAMAGED DURING THE PROCEDURE. THERE WERE NO POTENTIAL PATIENT ADVERSE EVENTS AND NO DELAY IN THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439101 ↗
• DeathOct 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CONTACT FROM THE FACILITY REPORTED THAT A FEMALE STUDY SUBJECT PRESENTED WITH A SUBARACHNOID HEMORRHAGE. HER HUNT AND HESS GRADE UPON ADMISSION TO THE HOSPITAL WAS 3. FOLLOWING PLACEMENT OF A VENTRICULOSTOMY CATHETER, THE PATIENT WAS BROUGHT TO THE ANGIOSUITE, AND A DIAGNOSTIC CEREBRAL WAS PERFORMED. ANGIOGRAM REVEALED A FUSIFORM DISSECTING ANEURYSM OF THE DISTAL BASILAR ARTERY. THE DECISION WAS TO TREAT THE ANEURYSM IN A STAGED FASHION, USING THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (CODMAN). THE INTENT WAS TO PLACE TWO STENTS INITIALLY WITHIN DISSECTING FUSIFORM DISTAL BASILAR ARTERY ANEURYSM FOR FLOW DIVERSION PURPOSES. THE INTENT WAS THEN TO PERFORM FOLLOW UP ANGIOGRAM IN 2 DAYS TO REASSESS ANEURYSM AND POSSIBLY TREAT WITH ADDITIONAL STENT PLACEMENT OR COILING DEPENDING ON ANEURYSM APPEARANCE AT FOLLOW UP. THE PATIENT'S HUSBAND WAS CONSENTED FOR THE PROCEDURE. TWO ENTERPRISE STENTS (ENF403912/10694541) AND (ENF402312/10632707) WERE PLACED IN THE BASILAR ARTERY, BRIDGING THE FUSIFORM ANEURYSM. THE DISTAL VESSEL DIAMETER WAS 2.25 MM AND THE PROXIMAL VESSEL DIAMETER WAS 2.9 MM. THE STENTS WERE PLACED WITHOUT COMPLICATION. ANGIOGRAM FOLLOWING STENT PLACEMENT REVEALED NO NO

  Patient problems: Death; Infarction, Cerebral

  MAUDE report 6031321 ↗