CERENOVUS ENTERPRISE ENF452800Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886704071785), received between Jul 29, 2024 and Oct 15, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (13 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.

• MalfunctionOct 15, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A 4.5MMD 25MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9664726) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31586957) 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 09-OCT-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 23289710 ↗
• MalfunctionOct 15, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 22MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200, 9682208) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31586957) 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-OCT-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS SO 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 23279700 ↗
• MalfunctionSep 10, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE USING THE DEVICES IN THE PATIENT, A 4.5MMD 28MML WNO DSTL TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9651821) WAS IMPEDED AT THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31557195) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR RETRACTED THE STENT AND SWITCHED TO A SECOND MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (606S255X, 31557195) TO DELIVER THE ORIGINAL STENT IN VITRO. THE STENT WAS STILL IMPEDED IN THE PROXIMAL END OF THE SECOND MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF THE MICROCATHETER. THE DOCTOR SWITCHED TO A THIRD MICROCATHETER AND A SECOND STENT, AND DELIVERED THEM IN PATIENT AND COMPLETED THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016244 ↗
• MalfunctionSep 8, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, 4.5MMD X 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WNO DSTL TIP (ENC452800, 9664726) WAS IMPEDED IN PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31586520) COULD NOT ADVANCE ANY MORE. THE DOCTOR RETRACTED THE STENT AND MICROCATHETER, THEN SWITCHED TO A SECOND MICROCATHETER, A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31586521) TO DELIVER THE ORIGINAL STENT IN THE PATIENT. THE STENT WAS WITH THE SAME ISSUE. THE DOCTOR REMOVED THE SECOND MICROCATHETER AND THE ORIGINAL SENT FROM THE PATIENT AND SWITCHED TO A THIRD MICROCATHETER AND A SECOND STENT TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 20 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-SEP-2025 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETERS DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 20 MINUTES PROCEDURE DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993659 ↗
• MalfunctionAug 25, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED VIA A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9584138) WAS IMPEDED WHEN THE STENT PASSED THE TIP OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN), A SHORT SECTION, AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE ORIGINAL MICROCATHETER. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883015 ↗
• MalfunctionAug 11, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 28MML VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9493885) WAS IMPEDED AT THE PROXIMAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUN-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE STENT IS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776495 ↗
• MalfunctionJul 8, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9568620) WAS IMPEDED IN THE MIDDLE OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31527351) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A SECOND STENT, A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9493885) AND A SECOND PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31140958), BUT THE SECOND STENT WAS WITH THE SAME ISSUE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A THIRD STENT AND A THIRD MICROCATHETER (BOTH WERE NON J&J PRODUCTS) TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436706 ↗
• MalfunctionJul 8, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9568620) WAS IMPEDED IN THE MIDDLE OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31527351) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A SECOND STENT, A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9493885) AND A SECOND PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31140958), BUT THE SECOND STENT WAS WITH THE SAME ISSUE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A THIRD STENT AND A THIRD MICROCATHETER (BOTH WERE NON-J&J PRODUCTS) TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436599 ↗
• MalfunctionJun 19, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 28MML WNO DSTL TP (ENC452800, 9477850) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS MICROCATHETER 150/5CM (606S255X, 3147112) 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 18-JUN-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 WERE NO PROCEDURE DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292739 ↗
• MalfunctionJun 10, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800, 8314209) WAS IMPEDED IN THE UNSPECIFIED MICROCATHETER HUB AND COULD NOT ADVANCE ANY MORE. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE PLACE WHERE THE MICROCATHETER HUB AND Y CONNECTOR CONNECT. THE DOCTOR REMOVED THE Y CONNECTOR AND REMOVED THE STENT AND THEN 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 09-JUN-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. A PROWLER SELECT PLUS 150/5CM (606S255X, UNKNOWN LOT) WAS USED. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURAL WAS DELAY/PROLONGED BY 20 MINUTES DUE TO THE EVENT. HOWEVER, THE PROCEDURE PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179359 ↗
• MalfunctionApr 29, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A 4.5MMD 28MML ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9185292) WAS IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) 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 29-APR-2025 INDICATED THAT THEY WERE NOT 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 3-4 MINUTES DUE TO THE EVENT. THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925962 ↗
• MalfunctionApr 23, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452800, 9320823) WAS IMPEDED IN PROXIMAL OF A PROWLER SELECT PLUS MICROCATHETER 150/5CM (606S255X, 31469832) AND COULD NOT ADVANCE ANY MORE. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC). 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-APR-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 PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891609 ↗
• MalfunctionNov 25, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE PHYSICIAN OPENED THE PACKAGING OF AN EU ENT4.5MMD 28MML WNO DSTL TP INTRACRANIAL STENT (ENC452800, 8962460) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772260 ↗
• MalfunctionNov 6, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE PHYSICIAN OPENED THE PACKAGING OF AN EU ENT4.5MMD 28MML WNO DSTL TP INTRACRANIAL STENT (ENC452800, 7632772) 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-NOV-2024 INDICATED THAT THERE WAS NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621234 ↗
• MalfunctionSep 25, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE EU ENT4.5MMD 28MML WNO DSTL TP (ENC452800/8598551) WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (MC) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT THE MICROCATHETER USED WAS PROWLER SELECT PLUS. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUCER. A CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE STENT HAS AN UNEXPECTED FOLD OR TWIST AND WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302993 ↗
• MalfunctionJul 29, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE PHYSICIAN OPENED DEVICE PACKAGING AND REMOVED THE EU ENT4.5MMD 28MML WNO DSTL TP INTRACRANIAL STENT DELIVERY SYSTEM (ENC452800, 7469245) FROM THE 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 EVENT INFORMATION RECEIVED ON 25-JUL-2024 INDICATED THAT THERE WERE NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851171 ↗