Events

Rappel de Device Recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 7.0 mm

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, Inc..

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
    67646
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1305-2014
  • Date de mise en oeuvre de l'événement
    2014-03-03
  • Date de publication de l'événement
    2014-03-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125901
  • 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
    Temporary Carotid Catheter for Embolic Capture - Product Code NTE
  • Cause
    Medtronic is recalling a specific subset of lot numbers of the fibernet embolic protection system (eps) where the yellow polyimide tube on the fibernet eps was not removed from the fibernet eps during the manufacturing process and subsequently may remain on the fibernet eps.
  • Action
    Medtronic sent an Urgent Device Recall letter dated March 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records show that your facility has received one or more of these FIBERNET EPS, as shown in the attachment to this notification. Consequently, Medtronic requests you immediately take the following actions: 1. Immediately remove and quarantine all potentially affected product that remains in your inventory. 2. Return these units to Medtronic. Contact Customer Service at 1-888- 283-7868 and reference RADAR # 174028 to initiate a return and credit of product. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email to RS.CFQFCA@Medtronic.com, or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Medtronic has taken the necessary steps to prevent any future shipment of the potentially affected product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. lf any FIBERNET EPS within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product. We apologize for the inconvenience this may cause you; please be assured that patient safety and product quality remain our primary concern. Should you have any questions, please contact your Medtronic representative or Medtronic LifeLine Technical Services at 1 (877) 526-7890 or (+1 763) 526-7890.

Device

Device Recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 7.0 mm
  • Modèle / numéro de série
    US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
  • Description du dispositif
    FIBERNET Embolic Protection System: || Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: || 0.014 in (0.36mm) || Rx only, Sterile; || Manufactured in: || Invatec S.P.A., Italy; || Manufacturer: || Medtronic Inc. || Minneapolis, MN. || The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • Adresse du fabricant
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • 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