Events

Recall of Pivot

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

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
    35301
  • Event Risk Class
    Class 2
  • Event Number
    Z-0895-06
  • Event Initiated Date
    2006-04-26
  • Event Date Posted
    2006-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45757
  • 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, Continuous Flush - Product Code KRA
  • Reason
    During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
  • Action
    On 4/25/06, the firm initiated the recall notification via letters explaining the reason for the recall and requesting the product be returned.

Device

Pivot
  • Model / Serial
    All codes.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was released for distribution to 51 consignees in US and 12 foreign consignees: Finland, Austria, Belgium, The Netherlands, Great Britain, Italy, France, Spain, Germany, Poland, Russia and Hong Kong. There were no shipments to U.S. Government facilities or Canadian distribution.
  • Product Description
    Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, || Catalog #: 1721, Universal Product Number: M00317210, || Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Orton Cir. West Valley City, UT 84119
  • Manufacturer
    Boston Scientific Target

Manufacturer

Boston Scientific Target
  • Manufacturer Address
    Boston Scientific Target, 4701 Lakeview Blvd, Fremont CA 94537
  • Source
    USFDA