Events

Recall of Device Recall POWERSAIL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Vascular-Cardiac Therapies dba Guidant Corporation.

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
    52705
  • Event Risk Class
    Class 1
  • Event Number
    Z-1806-2009
  • Event Initiated Date
    2009-06-17
  • Event Date Posted
    2009-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83684
  • 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
    Coronary Dilatation Catheter - Product Code MAF
  • Reason
    Distal shaft of the powersail coronary dilatation catheters exhibits damage that may result in a leak of contrast material and functional failures.
  • Action
    Abbott Vascular sent an Urgent Device Recall letter (w/return form) to customers on June 17, 2009 requesting return of identified products to Abbott Vascular Territory Manager. Abbott Vascular issued a press release dated July 28, 2009.

Device

Device Recall POWERSAIL
  • Model / Serial
    Lot 8012151(exp 12-2009)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.
  • Product Description
    POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) || Part #1005522-18
  • Manufacturer
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Manufacturer

Abbott Vascular-Cardiac Therapies dba Guidant Corporation
  • Manufacturer Address
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA