Events

Recall of Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore

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
    54687
  • Event Risk Class
    Class 1
  • Event Number
    Z-2218-2010
  • Event Initiated Date
    2009-12-04
  • Event Date Posted
    2010-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89016
  • 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
    Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring - Product Code NWX
  • Reason
    Separations of the ptca catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.
  • Action
    AngioScore sent an "Urgent: Medical Device Voluntary Recall" dated December 4, 2009 addressed to "Catheterization Lab Manager" at consignees. The Recall notification letter instructed consignees to inspect their inventory to detect product from the involved lot, and segregate it from their inventory. Consignees were asked to record all affected product and fax return forms to the firm. AngioScore Customer Service will contact consignees and provide instructions for return and replacement of affected product.. Consignees can contact AngioScore at 877-264-4692.

Device

Device Recall AngioSculpt PTCA Scoring Balloon Catheter, manufactured by Angioscore
  • Model / Serial
    Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. || Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.
  • Manufacturer
    AngioScore Inc.

Manufacturer

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