Events

Recall of Device Recall AngioSculpt PTCA Scoring Balloon Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AngioScore Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46149
  • Event Risk Class
    Class 3
  • Event Number
    Z-0591-2008
  • Event Initiated Date
    2007-11-13
  • Event Date Posted
    2008-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66884
  • Notes / Alerts
    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.
  • Extra notes in the data
    Balloon Catheter - Product Code NWX
  • Reason
    Mis-labeling: product labeling on product pouch indicates wrong size, the correct size is on the product carton.
  • Action
    The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.

Device

Device Recall AngioSculpt PTCA Scoring Balloon Catheter
  • Model / Serial
    Lot Number: F07090015
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.
  • Product Description
    AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
  • Manufacturer
    AngioScore Inc.

Manufacturer

AngioScore Inc.
  • Manufacturer Address
    AngioScore Inc., 5055 Brandin Ct, Fremont CA 94538-3140
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA