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181 stories matching this filter · ← front page

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  • Early Alert: Percutaneous Catheter Issue from Boston Scientific
    ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use
    fda medwatch · 5d ago↗ source
  • Early Alert: Intravascular Administration Set Issue from Baxter
    Baxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.
    fda medwatch · 9d ago↗ source
  • Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
    Prolonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation.
    fda medwatch · 12d ago
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  • Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
    Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.
    fda medwatch · 12d ago↗ source
  • Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
    B. Braun is removing affected convenience kits containing recalled Bupivacaine Hydrochloride in Dextrose Injection components
    fda medwatch · 13d ago↗ source
  • Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
    Saline, Lidocaine and Bupivacaine from affected convenience kits should not be used.
    fda medwatch · 13d ago↗ source
  • Early Alert: Ventilator Issue from Resmed
    Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death
    fda medwatch · 14d ago↗ source
  • Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
    Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
    fda medwatch · 15d ago↗ source
  • Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
    The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.
    fda medwatch · 16d ago↗ source
  • Early Alert: Convenience Kit Issue from Medical Action Industries
    Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
    fda medwatch · 20d ago↗ source
  • Early Alert: Convenience Kits Issue from Medline
    Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
    fda medwatch · 20d ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
    A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
    fda medwatch · 22d ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
    If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
    fda medwatch · 22d ago↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 23d ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 27d ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 27d ago↗ source
  • Dr Meeks on a Real-World Study of BCG Retreatment After BCG Failure in NMIBC
    Joshua J. Meeks, MD, PhD, discusses data from a real-world study of BCG retreatment after BCG failure in NMIBC.
    onclive · 2mo ago↗ source
  • Dr Hafron on a Multidisciplinary Quality Initiative Designed to Mitigate the AEs of ADT in Prostate Cancer
    Jason Hafron, MD, discusses findings from a study that evaluated the implementation of a multidisciplinary quality initiative in prostate cancer.
    onclive · 2mo ago↗ source
  • Preoperative Intravesical Mitomycin-C Before TURBT Cuts Recurrence Risk by 77% in NMIBC Over 5 Years
    Two doses of intravesical mitomycin-C administered before TURBT produced a 77% reduction in the risk of recurrence or death vs TURBT alone in NMIBC.
    onclive · 2mo ago↗ source
  • Genomic Disease Burden Markers, PD-L1 Expression Predictive of pOR With Neoadjuvant Gem-iDRS ± Cetrelimab in MIBC
    A biomarker analysis of SunRISe-4 found that high baseline TMB, GBD, and PD-L1 expression were associated with pathologic overall response to the regimen.
    onclive · 2mo ago↗ source
  • Dr Croll on Radiographic Size Change vs irRVT After Neoadjuvant Therapy in RCC
    Benjamin Croll, MD, discusses findings from a study of the correlation between radiographic response and pathologic response in RCC.
    onclive · 2mo ago↗ source
  • FDA Approves T-DXd for Early-Stage HER2+ Breast Cancer
    The FDA approved trastuzumab deruxtecan for the adjuvant and neoadjuvant treatment of select early-stage HER2-positive breast cancer.
    onclive · 2mo ago↗ source
  • Dr Garzotto on Aglatimagene Besadenovec Plus Valacyclovir and EBRT in Localized Prostate Cancer
    Mark Garzotto, MD, discusses efficacy data with aglatimagene besadenovec plus valacyclovir and EBRT in localized prostate cancer.
    onclive · 2mo ago↗ source
  • Dr Cirstea on Sequencing Considerations in R/R Multiple Myeloma
    Diana Cirstea, MD, discusses sequencing considerations in relapsed/refractory multiple myeloma in the era of T-cell–redirecting therapies.
    onclive · 2mo ago↗ source
  • Dr Hafron on the FDA Approval of Adjuvant Atezolizumab in MRD+ MIBC
    Jason Hafron, MD, discusses the significance of the FDA approval of adjuvant atezolizumab for MRD+ muscle-invasive bladder cancer.
    onclive · 2mo ago↗ source