Events

Rappel de Device Recall Boston Scientific BLUE MAX" 20 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 Boston Scientific Corporation.

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
    54669
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1211-2010
  • Date de mise en oeuvre de l'événement
    2010-02-18
  • Date de publication de l'événement
    2010-03-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88966
  • 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, angioplasty, peripheral, transluminal - Product Code LIT
  • Cause
    Boston scientific corporation is conducting a medical device recall removal of specific lots/batches of the blue max and ultrathin diamond balloon dilatation catheters. boston scientific has determined that, the sterile barrier in the catheter packaging (i.E. outer pouch side seal) of the affected products may be compromised. an undetected breach in sterility of the outer pouch may lead to contami.
  • Action
    Two "URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED" letters dated February 17, 2010 and February 18, 2010 were sent to the customers. The letters described the Action Description, Affected Product and Recall Instructions. The customers should immediately discontinue use of and remove all affected recalled product from your inventory, segregate the product in a secure location for return to Boston Scientific, complete and return the enclosed Account Reply Verification Tracking Form (even if you do not have any product to return) -fax to: Customer Service Call Center (866) 213-1806, and package/ship the recalled product per instructions. Your local sales Representative can answer any questions that you may have regarding this Recall Removal. If you have any question, please contact (763) 494-7971.

Device

Device Recall Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter
  • Modèle / numéro de série
    12936826, 12936827, 12936828, 12938360
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS.
  • Description du dispositif
    Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420 (BMQ/7-4/5.8/40, 12-542), M001125630(BMQ/9-8/5.8/40, 12-563) Made in Ireland, Ballybrit Business Park, Galway, Ireland || Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA