Events

Rappel de Device Recall Riata ST Silicone Insulated Leads

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 CRMD.

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
    60571
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0458-2012
  • Date de mise en oeuvre de l'événement
    2011-11-28
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105847
  • 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
    Implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • Cause
    The recall was initiated because st. jude medical has confirmed the failures associated with all cause insulation failure on the st. jude medical riata and riata st silicone endocardial defibrillation leads with specific emphasis on externalized conductors.
  • Action
    St. Jude Medical sent a Medical Device Advisory Important Product Information Update letter dated November 28, 2011, Physician Communication dated December 15, 2010, Product Performance Report Extracts, and a Physician Device Advisory Notification to physicians by FedEx priority overnight service for receipt on November 29, 2011. The letters provides the customers with an explanation of the problem, the product, and the actions to be taken. The issuance of the recall letter is in conjunction with St. Jude's recent release November 2011 Product Performance Report (available online at http://sjmprofessional.com). The letter also explains about the Lead Peformance Summary, Root Cause, Clinical Implications, Rate of Occurrence from Complaints and Returns, New Peer Reviewed Publications, Data on Optim Insulated Leads (Durata and Riata ST Optim), and Recommendations and Mitigations. Physicians with any questions or concerns can contact their local St. Jude Medical representative or the Technical Services Department at (800) 722-3774.

Device

Device Recall Riata ST Silicone Insulated Leads
  • Modèle / numéro de série
    Riata ST models (700X, 701X, 704X)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    USA (Nationwide) and worldwide to: Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Italy, Romania, Russia, Netherlands, Norway, Poland, Portugal, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, The Netherlands, UK, Australia, China, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, New Zealand, Argentina, Brazil, Colombia, Costa Rica, Ecuador, Mexico, Puerto Rico, Uruguay, Egypt, Greece, India, Iran, Israel, Joran, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, South Africa, Turkey, Malta, Cyprus, Iraq, Egypt, Lybia, Yemen, and U.A.E.
  • Description du dispositif
    St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 || Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy.
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Adresse du fabricant
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA