Rappel de Device Recall Medtronic Sutureless Pump Connector Revision Kit

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 Medtronic Neuromodulation.

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Sutureless Pump Connector Revision Kit - Product Code LKK
  • Cause
    Current labeling for medtronic sutureless connector (sc) catheters and revision kits (hereafter referred to as sc catheters) incorrectly states that sc catheters are compatible with medtronic isomed¿ constant-flow infusion pumps. sc catheters are compatible with medtronic synchromed¿ ii and synchromed el pumps. medtronic has determined that sc catheters are not compatible with isomed pumps.
  • Action
    A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants. A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card. Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".


  • Modèle / numéro de série
    Model 8578 used with all IsoMed Pump Models including 8472. Not lot or serial number specific.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution -- US (including Washington D.C. and Puerto Rico), Algeria, Aruba, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Poland, Portugal, Reunion, Romania, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City.
  • Description du dispositif
    Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8578 revision kit catheter connects to the catheter interface with a connector pin and strain-relief sleeve. The catheter interface connects to the pump with a sutureless pump connector. The 8578 revision kit is for use with 8709 and 8709SC catheters. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin and strain-relief sleeve. || This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space.
  • Manufacturer


  • Adresse du fabricant
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source