Events

Rappel de Device Recall TurboPower

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 Spectranetics Corp..

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
    73098
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0758-2016
  • Date de mise en oeuvre de l'événement
    2016-01-15
  • Date de publication de l'événement
    2016-02-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143064
  • 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, peripheral, atherectomy - Product Code MCW
  • Cause
    The product is labeled with an expiration date that is past its shelf life.
  • Action
    Spectranectics sent a Medical Device Field Action letter dated January 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and set aside the affected product and contact Customer Service at 1-800-231-0978 to arrange a product exchange. Customers were asked to document the return on the enclosed Field Action Acknowledgement and Receipt Form. Customers with additional questions were instructed to contact their local Spectranetics sales representative. For questions regarding this recall call 719-447-2318.

Device

Device Recall TurboPower
  • Modèle / numéro de série
    Lot CMP15J28A
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to Florida, North Carolina and Pennsylvania.
  • Description du dispositif
    2.3mm Turbo-Power OTW, Manual, Model No 423-050 || Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.
  • Manufacturer
    Spectranetics Corp.

Manufacturer

Spectranetics Corp.
  • Adresse du fabricant
    Spectranetics Corp., 9965 Federal Dr, Colorado Springs CO 80921-3617
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA