Events

Rappel de Pipeline and Pipeline Flex

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 Micro Therapeutics Inc, Dba Ev3 Neurovascular.

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
    72165
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0120-2016
  • Date de mise en oeuvre de l'événement
    2015-09-04
  • Date de publication de l'événement
    2015-10-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140075
  • 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
    Intracranial aneurysm flow diverter - Product Code OUT
  • Cause
    The firm is recalling pipeline and pipeline flex embolization devices from u.S. since the devices were shipped with an eu version of the instructions for use.
  • Action
    The firm, Medtronic, sent a "Notification of Recall" letter dated 09/04/15 to its customers. The letter described the product, problem and actions to be taken. The firm's letter instructed that customers return the Pipeline Embolization Devices to Medtronic for replacement with the US version of product. The firm asks customers to take the following steps: 1) Stop using this product immediately. 2) Segregate this product from other Inventory. 3) Fill out the reply form and fax to the completed form directly to Customer Service at (800) 716-6700 or email to: andrew.schramm@medtronic.com. Customer Service will issue an RGA number for the return of the affected product back to Medtronic Neurovascular. 4) Upon receipt of an RGA number, write the RGA number on the FEDEX slip and send the product back to: Medtronic Neurovascular, Attention: Product Recall, 9775 Toledo Way, Irvine, CA 92618. Prepaid and preaddressed FEDEX slips are enclosed for convenience. 5. Once they receive the returned units, product replacement units will be shipped directly to customers. The local Neurovascular representative can also be available to assist in expediting the exchange of product. For any questions contact directly at 949-680-1340.

Device

Pipeline and Pipeline Flex
  • Modèle / numéro de série
    Pipeline Model Number Lot Number FA-77250-16V06 9724629 FA-77350-16V10 A024276 FA-77350-16V12 A012865 FA-77350-18Vl0 A013596 FA-77350-20V12 A012039 FA-77375-14V12 A013029 FA-77375-16Vl2 A011629 FA-77375-16Vl2 A029223 FA-77375-16Vl2 A031361 FA-77375-18V10 A024213 FA-77375-20Vl2 A029315 FA-77400-14V12 A012885 FA-77425-18V12 A026942 FA-77450-14V12 A013028 FA-77475-20Vl2 A012383 FA-77500-16Vl2 A029316   Pipeline Flex Model Number Lot Number PED-400-20VO1 9977371 PED-475-20V01 A047151 PED-375-18V01 9971250
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees.
  • Description du dispositif
    -Pipeline Embolization Device || -Pipeline Flex Embolization Device || The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. || The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
  • Manufacturer
    Micro Therapeutics Inc, Dba Ev3 Neurovascular

Manufacturer

Micro Therapeutics Inc, Dba Ev3 Neurovascular
  • Adresse du fabricant
    Micro Therapeutics Inc, Dba Ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 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