Events

Recall of Device Recall Riata ST Silicone Insulated Leads

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

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
    60571
  • Event Risk Class
    Class 1
  • Event Number
    Z-0458-2012
  • Event Initiated Date
    2011-11-28
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105847
  • 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
    Implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • Reason
    The recall was initiated because st. jude medical has confirmed the failures associated with all cause insulation failure on the st. jude medical riata and riata st silicone endocardial defibrillation leads with specific emphasis on externalized conductors.
  • Action
    St. Jude Medical sent a Medical Device Advisory Important Product Information Update letter dated November 28, 2011, Physician Communication dated December 15, 2010, Product Performance Report Extracts, and a Physician Device Advisory Notification to physicians by FedEx priority overnight service for receipt on November 29, 2011. The letters provides the customers with an explanation of the problem, the product, and the actions to be taken. The issuance of the recall letter is in conjunction with St. Jude's recent release November 2011 Product Performance Report (available online at http://sjmprofessional.com). The letter also explains about the Lead Peformance Summary, Root Cause, Clinical Implications, Rate of Occurrence from Complaints and Returns, New Peer Reviewed Publications, Data on Optim Insulated Leads (Durata and Riata ST Optim), and Recommendations and Mitigations. Physicians with any questions or concerns can contact their local St. Jude Medical representative or the Technical Services Department at (800) 722-3774.

Device

Device Recall Riata ST Silicone Insulated Leads
  • Model / Serial
    Riata ST models (700X, 701X, 704X)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    USA (Nationwide) and worldwide to: Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Italy, Romania, Russia, Netherlands, Norway, Poland, Portugal, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, The Netherlands, UK, Australia, China, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, New Zealand, Argentina, Brazil, Colombia, Costa Rica, Ecuador, Mexico, Puerto Rico, Uruguay, Egypt, Greece, India, Iran, Israel, Joran, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, South Africa, Turkey, Malta, Cyprus, Iraq, Egypt, Lybia, Yemen, and U.A.E.
  • Product Description
    St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 || Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy.
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Manufacturer Address
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA