Rappel de Covidien Endo GIA Articulating Reloads with Tri-Staple Technology

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic has identified the potential for the device to have a misassembled (reversed) sled component. the sled component is responsible for staple deployment. when the device is applied to tissue and fired, a misassembled sled may result in the tissue being transected without the deployment of staples to seal the point of transection. this may result in bleeding, immediate anastomotic leak, and/or the potential for death if this is used on a critical vascular structure such as the pulmonary artery and renal artery. internationally, medtronic have received one report of injury related to this issue. to date, there have been no reported injuries in australia.
  • Action
    Medtronic is advising customers to immediately discontinue use of the affected products. Unused product should be quarantined and returned to Medtronic by following the instructions outlined on the Customer Letter. Medtronic will arrange collection of stock from customers and issue a credit for returned goods.


  • Modèle / numéro de série
    Covidien Endo GIA Articulating Reloads with Tri-Staple TechnologyEndo GIA 45mm Articulating Medium/Thick Reload with Tri-Staple Technology Item Code: EGIA45AMT Lot: N7L0521KXARTG:181429 Endo GIA 45mm Extra Thick Black Articulating Reload with Tri-Staple TechnologyItem Code: EGIA45AXT Lots: N8A0907KX and N8A0146KX ARTG:181429Endo GIA 60mm Articulating Vascular/Medium Loading Unit with Tri-Staple TechnologyItem Code: EGIA60AVM Lot: N8B0088KX ARTG:186247
  • Classification du dispositif
  • Manufacturer


  • 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