CERENOVUS ENTERPRISE ENF403900Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886704075400), received between Oct 21, 2016 and Aug 18, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT AT A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.0MM DIA X 39MM WITH NO TIP ENTERPRISE®2 (ENF403900 / 9275835) WAS PREMATURELY DEPLOYED OUT OF THE INTRODUCER SHEATH. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834567 ↗
• MalfunctionAug 7, 2025Activation Failure; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX39MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403900, 9185298) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, IT WAS FOUND THAT DISTAL MARKERS OF THE STENT COULD NOT BE OPENED OR EXPANDED COMPLETELY AS INTENDED. THE DOCTOR RETRACTED THE STENT AND DELIVERED THE STENT TO RELEASE IT AGAIN, BUT THE DISTAL STENT MARKERS STILL FAILED TO OPEN COMPLETELY. THE DOCTOR ONLY RETRACTED THE STENT ALONE, THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUL-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THERE WAS CALCIFICATION NOTED. 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. THE PROCEDURE WAS DELAYED/PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742076 ↗
• MalfunctionJul 15, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY, AN ENTERPRISE2 4MMX39MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403900, 8697553) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X , 31527346) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509636 ↗
• MalfunctionJun 18, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PROCEDURE, AN ENTERPRISE2 4MMX39MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403900, 9020397) WAS IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, UNKNOWN LOT) 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. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283077 ↗
• MalfunctionJun 17, 2025Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025, THE 4MM X 39MM WITH NO TIP ENTERPRISE® 2 (ENF403900 / 9061896) WAS PREMATURELY DEPLOYED IN THE HUB OF THE CONCOMITANT MICROCATHETER (UNKNOWN UNSPECIFIED BRAND). NO NEGATIVE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22242318 ↗
• MalfunctionJun 17, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN 4MMX39MM ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE (ENCR403900, 9185298) WAS IMPEDED IN THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC) THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO A SECOND NEW PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) TO DELIVER THE SAME STENT, BUT THE STENT HA THE SAME ISSUE. THE DOCTOR REMOVED THE SECOND MICROCATHETER AND THE STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES (BOTH NON J&J BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-MAY-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 20-MINUTES PROCEDURE PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229401 ↗
• MalfunctionSep 11, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE PHYSICIAN OPENED DEVICE PACKAGING OF AN ENTERPRISE 2 4MMX39MM NO TIP INTRACRANIAL STENT (ENCR403900, 8269502) AND REMOVED THE DEVICE FROM DISPENSER HOOP. IT WAS FOUND THAT THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11-SEP-2024 INDICATED THAT THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. THE INNER POUCH WAS SECURELY SEALED. THERE WAS NO PACKAGING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192031 ↗
• MalfunctionJul 31, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, AN ENTERPRISE2 4MMX39MM NO TIP INTRACRANIAL STENT (ENF403900, 7835937) WAS PRE-MATURELY DEPLOYED OUT OF THE DISPENSER. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19876601 ↗
• MalfunctionMay 1, 2024Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE TWO 4.0MM DIA X 39MM WITH NO TIP ENTERPRISE® 2 (B)(6) FROM THE SAME LOT NUMBER (8512189) WERE PREMATURELY DEPLOYED IN THE MICROCATHETER HUB. THE PHYSICIAN REPLACED THE PRODUCTS AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH THE THIRD STENT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226590 ↗
• MalfunctionMay 1, 2024Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE TWO 4.0MM DIA X 39MM WITH NO TIP ENTERPRISE® 2 (ENF403900) FROM THE SAME LOT NUMBER (8512189) WERE PREMATURELY DEPLOYED IN THE MICROCATHETER HUB. THE PHYSICIAN REPLACED THE PRODUCTS AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH THE THIRD STENT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226588 ↗
• MalfunctionJan 18, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING ENTERPRISE2 4MMX39MM NO TIP (ENF403900/ 7835937) THROUGH A PROWLER SELECT PLUS MICROCATHETER. THEREFORE, THE PHYSICIAN PULLED BACK THE STENT OUT OF THE PATIENT¿S BODY SAFELY. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE DELIVERY WIRE WAS FOUND SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18538046 ↗
• MalfunctionDec 4, 2023Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-OP OF A VASCULAR STENT PLACEMENT PROCEDURE, THE COMPLAINT DEVICE, A 4.0MM DIA X 39MM WITH NO TIP ENTERPRISE®2 STENT (ENF403900 / 7507671) WAS PRE-DEPLOYED OUT OF THE DISPENSER. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259727 ↗
• MalfunctionJul 24, 2023Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, AN ENTERPRISE2 4MMX39MM NO TIP INTRACRANIAL STENT (ENF403900, 7507671) WAS PRE-DEPLOYED, WHEN IT WAS OPENED. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381293 ↗
• MalfunctionOct 8, 2018Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ENTERPRISE®2 4.0 MM DIA X 39 MM WITH NO TIP (ENF403900/LOT# NOT AVAILABLE) PREMATURELY DEPLOYED IN THE DELIVERY MICROCATHETER DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944799 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION, HYPERLIPEMIA, PERIPHERAL VASCULAR DISEASE, SMOKING, AND PERCUTANEOUS STENTING OF A SEVERE ASYMPTOMATIC 70% LEFT CAROTID STENOSIS, DEVELOPED MILD EXPRESSIVE APHASIA AND VISUAL DISTURBANCE ON (B)(6) 2018, TRANSIENT RIGHT PRONATOR DRIFT FROM (B)(6) 2018, TRANSIENT MILD LEFT ARM WEAKNESS FROM (B)(6) 2018, AND AN MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2018 REVEALED A LEFT TEMPORAL PARIETAL PARENCHYMAL HEMORRHAGE. THE PATIENT WAS TRANSFERRED FROM THE INTENSIVE CARE UNIT (ICU) TO THE PROGRESSIVE CARE UNIT ON (B)(6) 2018. THE PATIENT WAS ALERT AND ORIENTED, AND PARTICIPATED IN PHYSICAL, SPEECH, AND OCCUPATIONAL THERAPY, BUT CONTINUED TO HAVE EXPRESSIVE APHASIA. THE PATIENT DID NOT WISH TO CONSIDER ANY SKILLED NURSING FACILITY OR INPATIENT REHABILITATION UPON DISCHARGE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2018 WITH DUAL ANTIPLATELET THERAPY AND PRESCRIPTION FOR OUTPATIENT SPEECH THERAPY FOR ONGOING OUTPATIENT REHABILITATION. THE PATIENT INITIALLY PRESENTED TO THE HOSPITAL ON (B)(6) 2018 WITH HIGH-GRADE STENOSIS OF THE LEFT INTERNAL CAROTID ARTERY (ICA) IN THE SETTING OF RIGHT C

  Patient problems: Intracranial Hemorrhage; Neurological Deficit/Dysfunction

  MAUDE report 7776845 ↗
• MalfunctionOct 21, 2016Difficult to Remove; Difficult to Remove

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO RECAPTURE THE ENTERPRISE 2 (ENF403900/10579509), BUT THE STENT WOULD NOT COME ALL OF THE WAY BACK INTO THE 0.021 PROWLER SELECT PLUS MICROCATHETER (606S252X/LOT UNK). HE HAD TO REMOVE THE ENTIRE SYSTEM FROM THE PATIENT, AND USED A SECOND STENT (ENF403000) WITH NO ADDITIONAL ISSUES. THERE WAS NO PATIENT EFFECT, AND THE PROCEDURE WAS ABLE TO BE COMPLETED USING THE SECOND STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6046921 ↗