Events

Rappel de Device Recall Epicor Ultra Wand LP Handheld Ablation Device

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 Atrial Fibrillation Division Inc.

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
    53611
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1780-2010
  • Date de mise en oeuvre de l'événement
    2009-06-15
  • Date de publication de l'événement
    2010-06-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86030
  • 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
    Surgical device, for ablation of cardiac tissue - Product Code OCL
  • Cause
    The firm states that overheating of cardiac tissue is caused by inadequate cooling. the potential exists when the ultrawand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. to reflect this information to the user, the atrial fibrillation division (afd) has.
  • Action
    St. Jude Medical issued a Market Bulletin, dated 06/15/2009, to their Field Representatives who were instructed to contact customers to make them aware that changes were made to the Instructions for Use (IFU) by SJM and that the customer may notice an extra IFU included in the shipping package. All such worldwide regulatory approvals will be needed before a revised IFU can eventually be included directly within the device package (as opposed to the shipping box). Existing instructional materials including the Epicor LP System Set-up ACS hang sheet and the EpicorLP In-service slides are being revised to reflect the UltraWand LP IFU changes The forthcoming Epicor LP In-service video is also being updated to reflect these changes. An Important Medical Device Safety Information letter, dated 11/06/2009 was sent via FedEx beginning 11/10/2009 to all US customers and will also shipped to all OUS customers beginning 11/13/2009. A copy of the new IFU will be sent with the letter which is being sent to all customers that have purchased or consigned the SJM UltraWand LP product since its commercial release in July of 2008. The customer notification includes the SJM Marketing managers and director for questions on the action.

Device

Device Recall Epicor Ultra Wand LP Handheld Ablation Device
  • Modèle / numéro de série
    Products with a serial number lower than 93859.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. OUS to include Australia, Canada, Japan, Korea, Singapore
  • Description du dispositif
    St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA
  • Manufacturer
    St. Jude Medical Atrial Fibrillation Division Inc

Manufacturer

St. Jude Medical Atrial Fibrillation Division Inc
  • Adresse du fabricant
    St. Jude Medical Atrial Fibrillation Division Inc, 240 Santa Ana Ct, Sunnyvale CA 94085-4512
  • 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