Events

Rappel de Device Recall Livewire TC" 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 Cardiovascular Division.

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
    48740
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2313-2008
  • Date de mise en oeuvre de l'événement
    2008-06-05
  • Date de publication de l'événement
    2008-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72033
  • 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
    St. jude medical has initiated a recall of one lot of livewire tc" ablation catheter. the product was mis-labelled as having an 8 mm tip instead of 4 mm tip. this could potentially result in elevated temperatures and formation of coagulum at the tip electrode. if this coagulum were to detach from the product, the worst case this could potentially result in embolization.
  • Action
    Consignees were sent a "St Jude Medical Urgent Product Recall" letter addressed to "Dear Doctor" and a "Doctor's Acknowledgement Form" . The letter described the product, problem and the possibility of a health hazard. They also requested discontinue of product and gave instructions for return of product. Contact St. Jude Medical at 952-933-4700 if you have questions.

Device

Device Recall Livewire TC" Ablation Catheter
  • Modèle / numéro de série
    Lot # 2056960
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Canada and Belgium
  • Description du dispositif
    The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO || The St. Jude Medical Livewire TC" Ablation Catheter is a flexible electrode catheter constructed of a radiopaque polyurethane insulation/shaft and incorporated platinum electrode. The distal tip portion may be deflected by a remote control handle located a t the proximal end of t the catheter.
  • Manufacturer
    St. Jude Medical Cardiovascular Division

Manufacturer

St. Jude Medical Cardiovascular Division
  • Adresse du fabricant
    St. Jude Medical Cardiovascular Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • 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