Events

Rappel de Device Recall Impulse Angiographic 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 Boston Scientific.

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
    45903
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0935-2008
  • Date de mise en oeuvre de l'événement
    2007-11-20
  • Date de publication de l'événement
    2008-01-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-10-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66450
  • 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
    Intravascular Diagnostic Catheter - Product Code DQO
  • Cause
    Flash may be protruding from the lumen of the catheter shaft. if this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.
  • Action
    The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****

Device

Device Recall Impulse Angiographic Catheter
  • Modèle / numéro de série
    Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.  16599-301/H749165993010/H749165993010/0020032538 and  16599-301/H749165993010/H749165993010/002003517
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.
  • Description du dispositif
    Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Adresse du fabricant
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA