Events

Rappel de Device Recall NC Trek RX Coronary Dilatation 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 Abbott Vascular.

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
    76841
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2038-2017
  • Date de mise en oeuvre de l'événement
    2017-03-22
  • Date de publication de l'événement
    2017-05-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154376
  • 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
    Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
  • Cause
    Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
  • Action
    An Urgent Field Safety Notice dated 3/22/17 was sent to customers to inform them that Abbott Vascular is recalling the NC Trek RX Coronary Dilation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PCTA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The letter informs the customers of how does the issue occur and what action is Abbott Vascular asking the customers to take. Customers with any questions are instructed to contact local Abbott Vascular Representative or Customer Service Department at (800) 227-9902. On 5/15/17, Abbott Vascular posted a press release on their website to inform customers that Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.

Device

Device Recall NC Trek RX Coronary Dilatation Catheter
  • Modèle / numéro de série
    Lot Number 61209G1 61209G2 61102G1 61102G1 61012G1 61209G1 61101G1 60415G1 61209G1 61102G1 61101G1 61101G1 61102G1 60415G1 61102G1 61101G1 60415G1 61209G1 61102G1 50415G1 50919G1 51110G1 61209G1 50919G1 51210G1 61101G1 61102G1 60415G1 61102G1 60415G1 61209G1
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US and Worldwide
  • Description du dispositif
    NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 || 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Adresse du fabricant
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • 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