Device Recall Medtronic Carmedacoated

Fabricante

  • Dirección del fabricante
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

11 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Catalog / Lot: 71166 / 9821992, 71166 / 9826735.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Descripción del producto
    Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber. Single Use gas exchange device for Cardiopulmonary Bypass. Catalog Number: 71166
  • Manufacturer
  • Modelo / Serial
    Catalog / Lot: CB0B90R3 / 9871463, CB0L44R15 / 9904942, CB0X97R10 / 9818263, CB1V99R2 / 9887322, CB1Y06R14 / 9872639, CB1Z42R15 / 9568381, CB1Z69R12 / 9805685, CB1Z69R12 / 9819156, CB1Z85R16 / 9816273, CB2503R1 / 9879856, CB2K59R8 / 9816253, CB2K59R8 / 9819175, CB2S52R4 / 9882568, CB2U05R1 / 9834608, CB2W86R2 / 9812228, CB3E29R5 / 9819173, CB3L87R4 / 9839338, CB3U53R7 / 9894969, CB3X44R4 / 9837298, CB4741R15 / 9823284, CB4E05R6 / 9892093, CB4F32R3 / 9819157, CB4F32R3 / 9819650, CB4F32R3 / 9867648, CB4G10R5 / 9885608, CB4Q81R / 9866753, CB4S04R2 / 9841997, CB4T12R2 / 9861563, CB4W67R3 / 9837302, CB5N65R2 / 9904072, HY1709R34 / 9818265, HY3B29R13 / 9895128, HY4X31R7 / 9864540, HY5C74R15 / 9838652, HY5H32R5 / 9879895, HY5L38R1 / 9859513, HY5L72R1 / 9882604, HY5R03R / 9861103, TL2L66R5 / 9859465
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Descripción del producto
    Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12, CB1Z69R12, CB1Z85R16, CB2503R1, CB2K59R8, CB2K59R8, CB2S52R4, CB2U05R1, CB2W86R2, CB3E29R5, CB3L87R4, CB3U53R7, CB3X44R4, CB4741R15, CB4E05R6, CB4F32R3, CB4F32R3, CB4F32R3, CB4G10R5, CB4Q81R, CB4S04R2, CB4T12R2, CB4W67R3, CB5N65R2, HY1709R34, HY3B29R13, HY4X31R7, HY5C74R15, HY5H32R5, HY5L38R1, HY5L72R1, HY5R03R, and TL2L66R5.
  • Manufacturer
  • Modelo / Serial
    Catalog / Lot: CB4014 / 9827678
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Descripción del producto
    Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014
  • Manufacturer
  • Modelo / Serial
    Catalog / Lot: CB511 / 9816345, CB5201R14 / 9828465, CB5227R4 / 9879857
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Descripción del producto
    Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.
  • Manufacturer
  • Modelo / Serial
    Catalog / Lot: CB67532 / 9816217
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Descripción del producto
    Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532
  • Manufacturer
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