BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 24302395 · Received February 10, 2026

    Report

    Report Number
    2242352-2026-0000065
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 18, 2026
    Report Date
    February 10, 2026
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TW (B)(4). UPDATED SECTIONS: B4, B5, D10, E1, G3, G6, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 02/04/2026. AN INVESTIGATION WAS CONDUCTED ON 02/10/2026. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. A GASH WAS OBSERVED ON THE SILICONE BALLOON THAT WAS PEELED BACK, EXPOSING THE PLASTIC BTT. NO OTHER VISUAL DEFECTS WERE OBSERVED. AN INFLATION TEST WAS NOT CONDUCTED DUE TO THE CONDITION OF THE TORN BALLOON. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "MATERIAL RUPTURE" WAS CONFIRMED. THE LOT # 3000513320 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT THE BTT BALLOON OF THE VASOVIEW HEMOPRO 2 BURST DURING THE CASE. BALLOON WAS INFLATED AND PERFORMED AS IT SHOULD WITH NO ISSUES BUT RANDOMLY BURST DURING THE CASE. AN ACCESSORY KIT WAS OPENED AND A NEW BTT WAS USED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT THE BTT BALLOON OF THE VASOVIEW HEMOPRO 2 BURST DURING THE CASE. BALLOON WAS INFLATED AND PERFORMED AS IT SHOULD WITH NO ISSUES BUT RANDOMLY BURST DURING THE CASE. THE INSUFFLATOR WAS RESPONDING APPROPRIATELY TO THE SETTINGS. THE CO2 INSUFFLATOR FLOW RATE WAS 3 AND THE PRESSURE SET AT 10. AN ACCESSORY KIT WAS OPENED AND A NEW BTT WAS USED. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341886 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000513320 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NO