WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Publicado el 10 de septiembre de 2025 · Inicio del retiro: 29 de julio de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Boston Scientific Corporation
- Distribuidor
- Worldwide.
- Lote
- GTIN 00191506013813, ALL NON-EXPIRED BATCHES
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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