Health Canada — Medical Devices · Canada · 2025-03-20 · Type II
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Reported risk: A portion of the catheter was detached and left in the patient's body during a clinical case in USA on Nov.21, 2024. The portion was retrieved by the physicians, and there was no patient injury reported. Health Canada FRN was submitted on Mar.8, 2024 following initiation of a voluntary recall in USA. As there is a probability that use of or exposure to the affected catheter lots may cause adverse health consequences, Conavi Medical Inc. proposes a voluntary recall of Novasight Hybrid Catheters in Canadian market starting March 12, 2025. Recall start date: Marc 12, 2025
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