Events

Rappel de Device Recall Angio kit

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.

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
    77144
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2548-2017
  • Date de mise en oeuvre de l'événement
    2017-05-03
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155656
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Cause
    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
  • Action
    All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.

Device

Device Recall Angio kit
  • Modèle / numéro de série
    228111X
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
  • Description du dispositif
    SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Adresse du fabricant
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • 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