Events

Rappel de Device Recall Biosense Webster MobiCath BiDirectional Guiding Sheath, Model D140010

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 Greatbatch 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
    76514
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2782-2017
  • Date de mise en oeuvre de l'événement
    2017-02-15
  • 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=153408
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    One side of the mobicath bi-directional guiding sheath pouch may not be sealed.
  • Action
    Consignee was sent a Greatbatch "Urgent Medical Device Recall" letter dated February 15, 2017 via UPS and email . The letter was addressed to Biosense Webster, Inc. The letter described the product involved in the recall, Reason for Recall, Risk to Health,& Instructions to Biosense Webster. Advised consignee to quarantine and return the devices, complete and return the field Recall Response Form to Stericycle, and to communicate the recall to their customers and end users. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8184 from 8:00 AM (CST) to 5:00 PM (CST), or e-mail us at FieldActionCenter@Greatbatch.com

Device

Device Recall Biosense Webster MobiCath BiDirectional Guiding Sheath, Model D140010
  • Modèle / numéro de série
    Model D140010, Lots: W3332609, W3338632, W3338635, W3338707, W3348350, W3348351, W3352503, W3359665, W3363850, W3363851, W3370052, W3374699, W3374700, W3379647, W3379650, W3384700, W3384701, W3390549, W3390551, W3397877, W3397879, W3397950, W3407814, W3407815, W3436351, W3436355, W3436356, W3436358, W3441735, W3441737, W3446767, W3446769, W3449392, W3451862, W3451863, W3455438,  W3455439, W3455440, W3459354, W3462467, W3462470, W3470335,  W3470336, W3483637, W3493240, W3497507, W3501348, W3501349,  W3581648, X3489776, X3497121, X3497510, X3501344, X3501345, X3503248,  X3507599, X3514814, X3518116, X3565743, X3581652, X3586059, X3592497.   Model D140011, Lots:
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA
  • Description du dispositif
    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). || The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Adresse du fabricant
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Société-mère du fabricant (2017)
    Integer Holdings Corporation
  • Source
    USFDA