FDAFDA · Alimentos y medicamentos·N.º oficial Z-0728-2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
Publicado el 20 de enero de 2021 · Inicio del retiro: 17 de noviembre de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Boston Scientific Corporation
- Distribuidor
- Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.
- Lote
- GTIN 08714729960904. All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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