Events

Rappel de Device Recall Target Detachable Coils

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 Stryker Neurovascular.

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
    74425
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2176-2016
  • Date de mise en oeuvre de l'événement
    2016-06-06
  • Date de publication de l'événement
    2016-07-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147577
  • 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
    Device, neurovascular embolization - Product Code HCG
  • Cause
    Stryker neurovascular has become aware that some units of target nano product do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
  • Action
    Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.

Device

Device Recall Target Detachable Coils
  • Modèle / numéro de série
    MODEL Number: M0035443060:  Lot Number/Expiration Date: 18826753 31-Jan-19 18826606 31-Jan-19 18794421 31-Jan-19 18777349 31-Dec-18 18750808 31-Dec-18 18754448 31-Dec-18 18760112 31-Dec-18 18491003 31-Jul-18 18443198 30-Jun-18 18827047 31-Jan-19 18816704 31-Jan-19 18776301 31-Dec-18 18750603 31-Dec-18 18491065 31-Jul-18 18442058 30-Jun-18 18808498 31-Jan-19 18783540 31-Jan-19 18764659 31-Dec-18 18750193 31-Dec-18 18708724 30-Nov-18 18491096 31-Jul-18 18443258 30-Jun-18 18443228 30-Jun-18 18393950 31-May-18 18817367 31-Jan-19 18782584 31-Jan-19 18755514 31-Dec-18 18703469 30-Nov-18 18443018 30-Jun-18 18442958 30-Jun-18 18442538 30-Jun-18 18441728 30-Jun-18 18436622 30-Jun-18 18827341 31-Jan-19 18809086 31-Jan-19 18809674 31-Jan-19 18765615 31-Dec-18 18750398 31-Dec-18 18471007 31-Jul-18 18490724 31-Jul-18 18818030 31-Jan-19 18760113 31-Dec-18 18708786 30-Nov-18 18490972 31-Jul-18 18442508 30-Jun-18 18442268 30-Jun-18 18827194 31-Jan-19 18703264 30-Nov-18 18490910 31-Jul-18 18442568 30-Jun-18 18827488 31-Jan-19 18826900 31-Jan-19 18808792 31-Jan-19 18443048 30-Jun-18 19013252 30-Apr-19 19000510 30-Apr-19 18951824 31-Mar-19 18853836 28-Feb-19 19028176 30-Apr-19 18990655 30-Apr-19 19041022 31-May-19 19040295 31-May-19 19000572 30-Apr-19 18960708 31-Mar-19 18902391 28-Feb-19 19013163 30-Apr-19 19066272 31-May-19 19063700 31-May-19 18975258 30-Apr-19 18974821 30-Apr-19 18905927 31-Mar-19 19028296 30-Apr-19 19013074 30-Apr-19 18952060 31-Mar-19 18951116 31-Mar-19 18905896 28-Feb-19 18901749 28-Feb-19 18990624 30-Apr-19 18952296 31-Mar-19 19028056 30-Apr-19 19012985 30-Apr-19 18975695 30-Apr-19 18943458 31-Mar-19 18926529 31-Mar-19 18903033 28-Feb-19 19027936 30-Apr-19 19039567 31-May-19 19000541 30-Apr-19 18960301 31-Mar-19 18951588 31-Mar-19 18943981 31-Mar-19 18883033 28-Feb-19 18925429 31-Mar-19 18944504 31-Mar-19.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
  • Description du dispositif
    Target Detachable Coils: || TARGET 360 NANO 3MM X 6CM || MODEL Number:M0035443060 || Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Adresse du fabricant
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA