Numen
MicroPort NeuroTech (Shanghai) Co., Ltd. · Model 3D4H14FR · UDI-DI 06958698009970
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-10 | Merit Medical Systems, Inc. | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, whi |
| 2025-05-29 | MICROVENTION INC. | Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targete |
| 2025-05-08 | BALT USA, LLC | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| 2025-04-17 | Cook Incorporated | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. |
| 2024-02-20 | Boston Scientific Corporation | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. T |
| 2024-01-03 | BALT USA, LLC | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold |
| 2023-08-24 | MICROVENTION INC. | Peripheral coil system detachable has a potential of unsealed pouch packaging. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
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