Events

Recall of Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter

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

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
    69512
  • Event Risk Class
    Class 2
  • Event Number
    Z-0177-2015
  • Event Initiated Date
    2014-10-14
  • Event Date Posted
    2014-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130784
  • 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, electrode recording, or probe, electrode recording - Product Code DRF
  • Reason
    St. jude medical is performing a voluntary recall of batch 4671318, model number 401353 of the response fixed curve deca 6f 65cm csl 2/8 catheter. specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (supreme fc quad 5f catheter) within the packaging. to date, no serious injuries have occurred as a result of this issue.
  • Action
    St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.

Device

Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter
  • Model / Serial
    Batch # 4671318
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CA, GA, NJ, NY, OR and PA.
  • Product Description
    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Address
    St Jude Medical, 1 Saint Jude Medical Dr, Saint Paul MN 55117-1789
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA