CERENOVUS ENTERPRISERecalls & reported problems across all models

We found 16 models of CERENOVUS ENTERPRISE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 478 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2016 and Sep 15, 2026 — classified as 5 deaths, 53 injuries, 420 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (241 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CERENOVUS ENTERPRISE problems

CERENOVUS ENTERPRISE models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CERENOVUS ENTERPRISE ENF402312

  intracranial neurovascular stent
  1 death90 reports
• CERENOVUS ENTERPRISE ENF402300

  intracranial neurovascular stent
  2 deaths66 reports
• CERENOVUS ENTERPRISE ENF403012

  intracranial neurovascular stent
  1 death42 reports
• CERENOVUS ENTERPRISE ENF452212

  intracranial neurovascular stent
  41 reports
• CERENOVUS ENTERPRISE ENF401612

  intracranial neurovascular stent
  36 reports
• CERENOVUS ENTERPRISE ENF401600

  intracranial neurovascular stent
  36 reports
• CERENOVUS ENTERPRISE ENF452812

  intracranial neurovascular stent
  31 reports
• CERENOVUS ENTERPRISE ENF403000

  intracranial neurovascular stent
  29 reports
• CERENOVUS ENTERPRISE ENF452200

  intracranial neurovascular stent
  25 reports
• CERENOVUS ENTERPRISE ENF453712

  intracranial neurovascular stent
  16 reports
• CERENOVUS ENTERPRISE ENF452800

  intracranial neurovascular stent
  16 reports
• CERENOVUS ENTERPRISE ENF403900

  intracranial neurovascular stent
  16 reports
• CERENOVUS ENTERPRISE ENF403912

  intracranial neurovascular stent
  1 death15 reports
• CERENOVUS ENTERPRISE ENF451412

  intracranial neurovascular stent
  8 reports
• CERENOVUS ENTERPRISE ENF451400

  intracranial neurovascular stent
  8 reports
• CERENOVUS ENTERPRISE ENF453700

  intracranial neurovascular stent
  3 reports

Recent CERENOVUS ENTERPRISE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776612 ↗
• MalfunctionMay 20, 2026Premature Activation

  IT WAS REPORTED THAT THE 4.0MM DIA X 16MM ENTERPRISE®2 (ENF401612 / 8302888) WAS PREMATURELY DEPLOYED WITHIN THE CATHETER HUB THEREFORE, RENDERED IT UNUSABLE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE STENT WAS PREMATURELY DETACHED AND WAS NO LONGER ON THE DELIVERY WIRE. THE INFORMATION CONFIRMED THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 12-MAY-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236313 ↗
• MalfunctionMay 20, 2026Premature Activation

  IT WAS REPORTED THAT THE 4.0MM DIA X 23MM ENTERPRISE®2 (ENF402312 / 10021142) WAS PREMATURELY DEPLOYED AT THE HUB AND SLIPPED OUT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 12-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE STENT WAS PREMATURELY DETACHED AND WAS NO LONGER ON THE DELIVERY WIRE. THE INFORMATION CONFIRMED THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 12-MAY-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232265 ↗
• MalfunctionMay 14, 2026Premature Activation

  IT WAS REPORTED THAT THE 4.0MM DIA X 16MM WITH NO TIP ENTERPRISE®2 (ENF401600 / 8697625) WAS PREMATURELY DEPLOYED AT THE HUB AND SLIPPED OUT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 12-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE STENT WAS PREMATURELY DETACHED AND WAS NO LONGER ON THE DELIVERY WIRE. THE INFORMATION CONFIRMED THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 12-MAY-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175294 ↗
• MalfunctionApr 27, 2026Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENF402300, LOT NUMBER: UNKNOWN) WAS SEPARATED FROM THE WIRE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002199 ↗
• MalfunctionApr 10, 2026Failure to Advance

  IT WAS REPORTED THAT THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING ENTERPRISE2 4MMX23MM NO TIP (ENF402300/ 9508489) THROUGH THE HUB OF AN UNSPECIFIED MICROCATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845464 ↗
• MalfunctionApr 9, 2026Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS EARLY DEPLOYMENT AT THE CATHETER HUB OF AN ENTERPRISE2 4MMX30MM VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENF403012, LOT NUMBER: 9664724). ADDITIONAL EVENT INFORMATION RECEIVED ON 24-MAR-2026 INDICATED THAT THE STENT PREMATURELY DETACHED AND NO LONGER ENGAGED ON DELIVERY WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832824 ↗
• MalfunctionApr 7, 2026Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0MM DIA X 23MM ENTERPRISE®2 (ENF402312 / 9584147) DEPLOYED EARLY. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, DURING THE DEVICE PREPARATION, THE STENT COMPONENT BECAME PREMATURELY DETACHED AND WAS NO LONGER ENGAGED / ATTACHED TO THE DELIVERY WIRE. THE TIP OF THE INTRODUCER CORRECTLY FIT INTO THE ROTATING HEMOSTASIS VALVE (RHV) AND THE HUB OF THE MICROCATHETER. THE INTRODUCER WAS SECURELY PLACED IN THE HUB PRIOR TO THE ATTEMPT TO ADVANCE THE DELIVERY WIRE. THERE WAS NO DAMAGE NOTED ON THE ASSOCIATED MICROCATHETER. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 26-MAR-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806109 ↗
• MalfunctionMar 19, 2026Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE STENT COMPONENT OF THE 4.0MM DIA X 23MM ENTERPRISE® 2 (ENF402312 / LOT# UNKNOWN) WAS PREMATURELY SEPARATED FROM THE DELIVERY WIRE IN THE INTRODUCER SHEATH. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 11-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOT NUMBER OF THE 4.0MM DIA X 23MM ENTERPRISE® 2 (ENF402312) WAS 9854676. THE REPLACEMENT DEVICE WAS ANOTHER 4.0MM DIA X 23MM ENTERPRISE® 2 (ENF402312). THERE WAS NO NEGATIVE PATIENT IMPACT. ALL OTHER INFORMATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640665 ↗
• MalfunctionMar 10, 2026Material Separation

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT THE STENT AND WIRE WERE OF AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENF402300, LOT NUMBER: UNKNOWN) WERE SEPARATED INSIDE THE ENCLOSED SHEATH, AND ONLY THE WIRE SLIPPED OUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559023 ↗
• MalfunctionFeb 26, 2026Retraction Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN ENTERPRISE2 4MMX16MM NO TIP (PRODUCT CODE: ENF401600, LOT NUMBER: 9493904) RECAPTURE FAILED WHEN DEPLOYED AT THE M1 SEGMENT STENOSIS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455393 ↗
• MalfunctionDec 22, 2025Premature Activation; Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE ENF402300, LOT NUMBER 9508489) PREMATURELY DEPLOYED OUT TO DISPENSER. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863113 ↗
• MalfunctionDec 9, 2025Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE WIRE ON THE 4.0MM DIA X 23MM WITH NO TIP ENTERPRISE® 2 (ENF402300 / 8640233) WAS BROKEN BEFORE THE DEVICE WAS USED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764318 ↗
• MalfunctionNov 7, 2025Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, A 4.0MM DIA X 30MM ENTERPRISE®2 (ENF403012 / 8994896) WAS USED, AND THE STENT WAS PREMATURELY DEPLOYED IN THE HUB OF THE CONCOMITANT PROWLER SELECT PLUS MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 07-NOV-2025. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503599 ↗
• MalfunctionNov 5, 2025Migration; Migration

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENF401600, LOT UNKNOWN) MIGRATED FROM THE DISTAL INTERNAL CAROTID ARTERY (ICA) TO THE PROXIMAL ICA, WHERE IT HAD BEEN INITIALLY DEPLOYED SUCCESSFULLY. AT 1 YEAR FOLLOW UP, IMAGING DEMONSTRATED THE MIGRATION OF THE STENT. THE PATIENT REMAINS ASYMPTOMATIC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477158 ↗

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