Events

Recall of CARTO 3 System Interface Cable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosense Webster, 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
    56986
  • Event Risk Class
    Class 2
  • Event Number
    Z-0884-2011
  • Event Initiated Date
    2010-10-05
  • Event Date Posted
    2011-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95116
  • 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
    Cable, transducer and electrode, patient, (including connector) - Product Code DSA
  • Reason
    When connecting this cable to the mapping system, loss of body surface ecg signals may occur. this may result in inaccurate locations appearing for catheters displayed 3d on the carto monitor.
  • Action
    Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form. For questions regarding this recall call Biosense Webster at 909 839-8874.

Device

CARTO 3 System Interface Cable
  • Model / Serial
    Part Number: D-1286-18; Catalog Number CR3410CT
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, and WV, and the countries of Belgium, China, Israel, Japan, Singapore, and Thailand.
  • Product Description
    CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT || This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA