Skip to content

Numen 3D0410FNRecalls & reported problems

MicroPort NeuroTech (Shanghai) Co., Ltd. · The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06958698011461), received between Mar 7, 2023 and Mar 7, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    DURING CASE THE PHYSICIANS DEPLOYED 2 SUCCESSFUL COILS INTO ANEURYSM WITH NO ISSUES. ON THIRD COIL, THE PHYSICIANS HAD DETACHMENT ZONE OF COIL PROPERLY LINED UP, AND HEARD THE 3 BEEPS FOR SUCCESSFUL DETACHMENT, PHYSICIAN PULLED BACK AS WELL TO MAKE SURE DETACHMENT OCCURRED AND DURING THAT TIME NOTHING WAS SEEN SO SUCCESSFUL DETACHMENT WAS ASSUMED. WHEN PULLING OUT MICROCATHETER THE PHYSICIANS REALIZED COIL WAS NOT DETACHED AND AT THAT POINT PHYSICIAN TRIED TO MOVE COIL BUT IT WAS NOT ABLE TO ADVANCE OR PULL BACK, ALMOST STUCK. FINALLY WHEN THE DETACHMENT ZONE WAS PAST MARKER THE END OF THE COIL POPPED OUT LEAVING A TAIL IN THE VESSEL. AN LVIS JR 3.5X14 WAS PLACED TO TACK THE COIL DOWN. THIS ADVERSE EVENTS WAS DUE TO COIL DID NOT DETACH PROPERLY AND RESULTED IN TAIL OF COIL IN ICA VESSEL AND A STENT WAS NEEDED TO TACK IT DOWN, AND THERE IS NO DEATH OR INJURY INVOLVED IN THIS CASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16500251 ↗

Other Device, Neurovascular Embolization devices

All Device, Neurovascular Embolization devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page