Device Recall Medtronic Carmedacoated

  • Modèle / numéro de série
    Catalog / Lot: CB78722 / 9807485
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Description du dispositif
    Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall wire-wound PVC bodies with angled, beveled tips. Catalog Number: CB78722
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Catalog / Lot: 71166 / 9821992, 71166 / 9826735.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog / Lot: CB4014 / 9827678
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Description du dispositif
    Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014
  • Manufacturer
  • Modèle / numéro de série
    Catalog / Lot: CB511 / 9816345, CB5201R14 / 9828465, CB5227R4 / 9879857
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Description du dispositif
    Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.
  • Manufacturer
  • Modèle / numéro de série
    Catalog / Lot: CB67532 / 9816217
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
  • Description du dispositif
    Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532
  • Manufacturer
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