Events

Rappel de Device Recall Medtronic Trillium Affinity

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Perfusion Systems.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    45485
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0476-2008
  • Date de mise en oeuvre de l'événement
    2007-10-01
  • Date de publication de l'événement
    2008-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-10-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65566
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Cardiopulmonary Bypass Oxygenator - Product Code DTZ
  • Cause
    Unnaproved component resin: affinity nt integrated cvr membrane oxygenators and el 240 autotransfusion blood collection reservoirs contain components made from an unapproved resin.
  • Action
    Medtronic sales force was notified and initiated calls with cutomers on 10/1/07. Additionally, certified Urgent Medical Device Recall letters dated 10/5/2007, were sent to the 32 customers. The letter explained the situaiton and requested that the impacted product be returned for replacement or credit. Medtronic is assessing patient use risks and will report those when determined. Standard post-surgical monitoring is advised at the present by Medtronic .

Device

Device Recall Medtronic Trillium Affinity
  • Modèle / numéro de série
    Lot Numbers 8870107 and 8851934 (both Model 541T )
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.
  • Description du dispositif
    Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Adresse du fabricant
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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