BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL

    MDR report key: 25123630 · Received May 8, 2026

    Report

    Report Number
    9616099-2026-00669
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATALOG NUMBER AND EVENT DATE ARE CURRENTLY UNKNOWN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED IN THE LITERATURE ARTICLE, MINOR COMPLICATIONS WERE INFREQUENT WHEN USING AN UNKNOWN EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WITH ONE CASE OF DEEP VEIN THROMBOSIS. IN A TOTAL OF 212 PATIENTS, NO MAJOR ACCESS-SITE COMPLICATIONS WERE REPORTED FOR EITHER THE HYDROGEL VASCULAR CLOSURE DEVICE OR THE EXOSEAL DEVICE. THESE FINDINGS DEMONSTRATE NO EVIDENCE OF A DEVICE-RELATED SAFETY SIGNAL FOR THE HYDROGEL VASCULAR CLOSURE DEVICE. THE DEVICE WILL NOT BE RETURNED. THIS REPORT IS SOURCED FROM LITERATURE ARTICLE BY YU, S., HUANG, Z., LYU, Z., LI, M., YE, B., ZENG, G., XU, J., WANG, H., HOU, J., LIU, Y., ZHAO, Y., GUO, Z., & XIAO, G. (2026).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493672 EXOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.