Events

Rappel de Device Recall MINDFRAME CAPTURE(TM) LP Revascularization 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 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
    79463
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1701-2018
  • Date de mise en oeuvre de l'événement
    2018-02-26
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162387
  • 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
    Catheter, thrombus retriever - Product Code NRY
  • Cause
    There is a potential issue for all mindframe capture devices to partially detach or separate from the delivery wire.
  • Action
    The firm initiated their recall via an Urgent Medical Device Recall letter, dated February 26, 2018. The letter identified the affected device, described the issue, product scope, and the actions to be taken. The firm recommended users remove and quarantine all affected and unexpired product in their inventory and return the affected products to Medtronic. Customers may contact their Medtronic representative if alternative product is needed. The Customer Confirmation Form should be completed and faxed to Medtronic at 1-949-434-5020, to the attention of Neurovascular Quality.

Device

Device Recall MINDFRAME CAPTURE(TM) LP Revascularization Device
  • Modèle / numéro de série
    All lot numbers: Product Number: UDI (a) REF 300010: 00843889031334, 00843889031341, 00847536020207 (b) REF 300011: 00843889031365, 00843889031372, 00847536020214 (c) REF 300012: 00843889031396, 00843889031402, 00847536020221 (d) REF 300013: 00843889031426, 00843889031433, 00847536020238 (e) REF 300014: NOT DISTRIBUTED (f) REF 300015: 00847536020122, 00847536020160 (g) REF 300016: 00847536020139, 00847536020177 (h) REF 300017: 00847536020146, 00847536020184 (i) REF 300018: 00847536020153, 00847536020191
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    MindFrame Capture LP Revascularization Devices: Product Numbers: || (a) REF 300010 || (b) REF 300011 || (c) REF 300012 || (d) REF 300013 || (e) REF 300014 || (f) REF 300015 || (g) REF 300016 || (h) REF 300017 || (i) REF 300018 || Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.
  • 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