Events

Recall of Device Recall Boston Scientific Constellation Advanced Mapping Catheter

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

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
    31230
  • Event Risk Class
    Class 2
  • Event Number
    Z-0639-05
  • Event Initiated Date
    2005-02-14
  • Event Date Posted
    2005-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37422
  • 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, Intracardiac Mapping, High-Density Array - Product Code MTD
  • Reason
    The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in ischemic events.
  • Action
    All consignees were notified via customer letters sent out on 02/14/2005. Distributors outside the US will be formally notified via the firm's recall procedures.

Device

Device Recall Boston Scientific Constellation Advanced Mapping Catheter
  • Model / Serial
    Model numbers 8031, 8038, 8048, 8060, 8075. 510(k) numbers K983171, K992777, K000277, K021232, K003782. Product Code DXQ. Product UPN numbers: Domestic: Constellation 31 mm/2mm: M004 US8031 0, M004 US8031 L0, M004 US8031 M0. 38mm/3mm: M004US8038 0, 4004 US8038 L0, M004 US8038P0. 48MM/4MM M004 US8048 0, M004 US8048B0, M004 US8048P0. 60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0. 75mm/7mm: M004 US0875 0, M004 US0875B0, M004 US8075P0.   Outside of US product: Constellation 31 mm/2mm: M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0. 38mm/3mm: M004EPT8038 0, 4004 EPT8038 L0, M004 EPT8038P0. 48MM/4MM M004 EPT8048 0, M004 EPT8048B0, M004 EPT8048P0. 60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0. 75mm/7mm: M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    This product was distributed to 521 accounts worldwide.
  • Product Description
    Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Address
    Boston Scientific, 2710 Orchard Pkwy, San Jose CA 95134-2012
  • Source
    USFDA