Events

Rappel de Device Recall Medtronic Everest 20cc Inflation Device

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 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
    67490
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1121-2014
  • Date de mise en oeuvre de l'événement
    2014-02-06
  • Date de publication de l'événement
    2014-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125544
  • 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
    Syringe, balloon inflation - Product Code MAV
  • Cause
    Incorrect master label.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter on February 6, 2014, via UPS 3-day delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product that remains in their inventory. Return the affected product to Medtronic: Contact Customer Service at 888-283-7868 and reference RADAR # 170276 to initiate a return and credit of product. Complete the attached Customers Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If any affected product has been forwarded to another facility, customers were asked to notify that facility accordingly and facilitate the retrieval of the affected product. Customers with questions were instructed to contact their Medtronic representative. For questions regarding this recall call 888-283-7868.

Device

Device Recall Medtronic Everest 20cc Inflation Device
  • Modèle / numéro de série
    Lot Number: 50755851
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
  • Description du dispositif
    Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P || The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Adresse du fabricant
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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
    USFDA