Events

Rappel de NC Sprinter; Rapid Exchange Balloon Dilatation Catheter

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
    66334
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2302-2013
  • Date de mise en oeuvre de l'événement
    2013-09-16
  • Date de publication de l'événement
    2013-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122073
  • 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
    Catheters, transluminal coronary angioplasty - Product Code LOX
  • Cause
    Compliance chart included in lot 207002011 of the nc sprinter rx 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter beginning September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that your facility has received affected NC Sprinter RX Balloon Dilatation Catheters as noted in the attached customer notification detail report. Consequently, Medtronic is asking you to take the following actions: 1. Remove and quarantine all affected catheters that remain in your inventory. 2. Return the affected catheters to Medtronic. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and fax it 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 mislabeled product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. If any NC Sprinter RX Balloon Dilatation Catheters 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 appreciate your cooperation and apologize for the inconvenience that this issue may cause. Should you have any questions, please contact your local Medtronic representative.

Device

NC Sprinter; Rapid Exchange Balloon Dilatation Catheter
  • Modèle / numéro de série
    Lot number 207002011; Exp 5-13-2015.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.
  • Description du dispositif
    NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; || Sterile; 2.25 mm; Model NCSP22512X. || Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 || The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque balloon marker(s) enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
  • 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