Events

Rappel de Device Recall CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillator

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 Boston Scientific CRM Corp.

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
    55216
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1558-2010
  • Date de mise en oeuvre de l'événement
    2010-03-15
  • Date de publication de l'événement
    2010-05-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90365
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization - Product Code NIK
  • Cause
    Boston scientific corporation has stopped shipment and is retrieving unimplanted devices from us hospital shelves of all its implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) after determining that some manufacturing process changes were not submitted for approval to the us food & drug administration.
  • Action
    BSC issues press release dated 15 March 2010. FDA press release posted 18 March 2010. On 15 March 2010, BSC Sales Representatives begin removal of devices from health care facilities stock. Starting 22 March 2010 BSC sent a physician letter dated 22 March 2010 to implanting and following physicians via FedEx. The Urgent Medical Device Recall letter described the issue of why devices were being removed from hospital shelves. The letter did NOT recommend any changes to normal follow-up procedures for patients implanted with an ICD or CRT-D device. The letter included ALL potential US models. To be complete and mitigate the possibility of retrieval errors, the ICD and CRT-D US models that may be on customer's shelves were included in the letter. The devices subject to retrieval, however, were those non-implanted devices with domestic customers. For questions, please contact the local representative (1-800-227-3422) for pick up and return or contact Boston Scientific Technical Services at 1.800.CARDIAC (227.3422).

Device

Device Recall CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillator
  • Modèle / numéro de série
    The device serial numbers are only provided for devices subject to the retrieval. For model number with no serial numbers there were no non-implanted devices with domestic customers. Once the required BSC submissions and FDA reviews are completed, the BSCs distribution and implant restrictions will no longer apply.  Model H175, no serial numbers will be retrieved. Model H170, serial numbers: 367529, 367531, 367582, 367593. Model H177, serial number 286645. Model H179, serial number 115199.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    nationwide within US only (OUS distribution not affected).
  • Description du dispositif
    CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac Resynchronization Therapy Defibrillator (CRT-D). These CRT-Ds provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Sterile EO. Boston Scientific Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Adresse du fabricant
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA