Events

Rappel de Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter

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 St Jude Medical.

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
    69512
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0177-2015
  • Date de mise en oeuvre de l'événement
    2014-10-14
  • Date de publication de l'événement
    2014-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130784
  • 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
    Catheter, electrode recording, or probe, electrode recording - Product Code DRF
  • Cause
    St. jude medical is performing a voluntary recall of batch 4671318, model number 401353 of the response fixed curve deca 6f 65cm csl 2/8 catheter. specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (supreme fc quad 5f catheter) within the packaging. to date, no serious injuries have occurred as a result of this issue.
  • Action
    St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.

Device

Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter
  • Modèle / numéro de série
    Batch # 4671318
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of CA, GA, NJ, NY, OR and PA.
  • Description du dispositif
    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Adresse du fabricant
    St Jude Medical, 1 Saint Jude Medical Dr, Saint Paul MN 55117-1789
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA