Events

Rappel de Device Recall MitraXs" Self Adjusting Atrial Retractor

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 Cardiovascular Division.

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
    57850
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1370-2011
  • Date de mise en oeuvre de l'événement
    2011-01-26
  • Date de publication de l'événement
    2011-02-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97576
  • 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
    Instruments, surgical, cardiovascular - Product Code DWS
  • Cause
    St. jude medical cardiovascular division is conducting a voluntary recall of all batches and model numbers of the mitraxs self adjusting atrial retractor. st. jude medical has been distributing this product since their acquisition of clr in late 2008. they have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. as these burrs may.
  • Action
    The firm, St. Jude Medical, sent an "Urgent Medical Device Recall Notice" dated January 26, 201,1 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue use of the product (MitraXs Self Adjusting Atrial Retractor batches) and remove from inventory. St. Jude began production of a new batch of units that will bear the labeling of St. Jude Medical. Shipment of these units started on January 10, 2011. Note: A St. Jude Medical Sales Representative will contact the customer to facilitate removal and reconciliation of the affected product. If you have any questions or concerns, please contact your St. Jude Medical Sales Representative or 651-490-4470 and/or 612-310-7936.

Device

Device Recall MitraXs" Self Adjusting Atrial Retractor
  • Modèle / numéro de série
    Model - Batch #:  A0030/1 - 32730001; 32765005; 33253005; 347830070  A0031/1 - 32730003; 32765007; 347830080; 33253006  A0032/1 - 32730002; 32765006; 34783090; 32985001  A0033/1 - 32765008; 33253007; 347830100
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: NJ, OH, MI, and MN; and countries including: BELGIUM, FRANCE, GERMANY, SWITZERLAND, and UNITED KINGDOM.
  • Description du dispositif
    MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. || Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.
  • Manufacturer
    St. Jude Medical Cardiovascular Division

Manufacturer

St. Jude Medical Cardiovascular Division
  • Adresse du fabricant
    St. Jude Medical Cardiovascular Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • 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