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-2170-2016
  • 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=147558
  • 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: M0035431530:  Lot Number/Expiration Date: 18758254 31-Dec-18 18685258 30-Nov-18 18651285 31-Oct-18 18637564 31-Oct-18 18426876 31-May-18 18802748 31-Jan-19 18758459 31-Dec-18 18709486 30-Nov-18 18637506 31-Oct-18 18551662 31-Aug-18 18551894 31-Aug-18 18551778 31-Aug-18 18503529 31-Jul-18 18466471 30-Jun-18 18841964 31-Jan-19 18829601 31-Jan-19 18758049 31-Dec-18 18767569 31-Dec-18 18685548 30-Nov-18 18651227 31-Oct-18 18551604 31-Aug-18 18830630 31-Jan-19 18843698 28-Feb-19 18842831 31-Jan-19 18637390 31-Oct-18 18592500 30-Sep-18 18557240 31-Aug-18 18627281 31-Oct-18 18776363 31-Dec-18 18767070 31-Dec-18 18732530 30-Nov-18 18551836 31-Aug-18 18453506 30-Jun-18 18815140 31-Jan-19 18814270 31-Jan-19 18780961 31-Jan-19 18766571 31-Dec-18 18637448 31-Oct-18 18522949 31-Jul-18 18518477 31-Jul-18 18801433 31-Jan-19 18777411 31-Dec-18 18735646 31-Dec-18 18734430 30-Nov-18 18685838 31-Oct-18 18722263 30-Nov-18 18458818 30-Jun-18 18402198 31-May-18 19049471 31-May-19 19005345 30-Apr-19 18975463 30-Apr-19 18895272 28-Feb-19 18985193 30-Apr-19 19005403 30-Apr-19 19060071 31-May-19 18974589 30-Apr-19 18944128 31-Mar-19 18943082 31-Mar-19 19032025 30-Apr-19 18950234 31-Mar-19 18862184 28-Feb-19 18860682 28-Feb-19 18877220 28-Feb-19 19031155 30-Apr-19 18949886 31-Mar-19 18949712 31-Mar-19 18896142 28-Feb-19 18895852 28-Feb-19 18859219 28-Feb-19 18889081 28-Feb-19 19031445 30-Apr-19 18928887 31-Mar-19 18928128 31-Mar-19 19005287 30-Apr-19 18974152 30-Apr-19 18950060 31-Mar-19 18944651 31-Mar-19 18888559 28-Feb-19 19031735 30-Apr-19 19050513 31-May-19 18975026 30-Apr-19 18888037 28-Feb-19 18943605 31-Mar-19 18927369 31-Mar-19 18894982 28-Feb-19 18876352 28-Feb-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 HELICAL NANO 1.5 MM X 3 CM || MODEL Number:M0035431530 || 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