Events

Rappel de Device Recall Therapy Ablation Catheter

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.

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
    59683
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3256-2011
  • Date de mise en oeuvre de l'événement
    2011-02-10
  • Date de publication de l'événement
    2011-09-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103273
  • 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
    Cardiac Ablation Percutaneous Catheter - Product Code LPB
  • Cause
    The recall was initiated because st. jude medical has confirmed that the therapy ablation catheter, 4 mm tip thermistor quadripolar, were packaged with the incorrect instructions for use (ifu). to ensure accuracy of device labeling, st. jude medical is requesting that the incorrect ifu be replaced with the enclose, correct version.
  • Action
    St. Jude Medical sent an "important Medical Device Safety Information" letter dated February 22, 2011 to all affected customers. The letter includes: affected problem, reconciliation form and corrective action. Customers are asked to remove the incorrect Instructions for Use (IFU) and use the IFU provided in the letter, and to fill out and return the reconciliation form. For questions on this recall please contact the firm at (512) 329-1054 or (651) 756-2869.

Device

Device Recall Therapy Ablation Catheter
  • Modèle / numéro de série
    Model: 83725. Lots: 3200476, K21432, K24495, K25197, K28752, K30681, and K30881.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
  • Description du dispositif
    7 F Therapy Ablation Catheter, || 4 mm Tip Thermistor, || Model (Reorder #) 83725, || Description: 1304-7-25-L-TH. || St Jude Medical Company || A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Adresse du fabricant
    St Jude Medical, One St Jude Medical Dr, Saint Paul MN 55117
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA