BEUDAMED
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    SMALL PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 5, 2011

    2CM PERIPHERAL CUTTING BALLOON®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·August 27, 2015

    AGENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·October 28, 2025

    AGENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·January 22, 2026

    AGENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·January 22, 2026

    AGENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code OOB·October 28, 2025

    Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.

    FDA Recall
    Terminated ·Spectranetics Corporation·Product code NWX·December 7, 2018

    AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code NWX·December 4, 2009

    AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.

    FDA Recall
    Terminated ·AngioScore Inc.·Product code NWX·November 13, 2007

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA classification
    FDA Class 3 ·Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·November 9, 2016

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·October 25, 2016

    SMALL PERIPHERAL CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·December 16, 2016

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·November 30, 2016

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·October 27, 2016

    FLEXTOME® CUTTING BALLOON®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·November 1, 2016

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·December 22, 2016

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·October 17, 2016

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·October 10, 2016

    FLEXTOME¿ CUTTING BALLOON¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NWX·December 15, 2016