Events

Recall of Device Recall AngioSculpt PTA 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
    57271
  • Event Risk Class
    Class 1
  • Event Number
    Z-0840-2011
  • Event Initiated Date
    2010-11-16
  • Event Date Posted
    2011-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95718
  • 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
    vascular balloon catheter - Product Code DQY
  • Reason
    Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. may result in vessel injury or embolism.
  • Action
    Medical Device Recall notifications were sent to all domestic consignees on Nov 16, 2010 by overnight mail. Foreign distributors, other than Japan, were sent recall letters by e-mail or international overnight delivery on November 16, 2010. The Japanese distributor received notification and notified their customers on November 10, 2010.

Device

Device Recall AngioSculpt PTA Scoring Balloon Catheter
  • Model / Serial
    Part (REF) number: 2076-6020: All lot codes
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
  • Product Description
    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020.
  • Manufacturer
    AngioScore Inc.

Manufacturer

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