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.
This recall has been terminated (originally issued January 11, 2012).
- Company
- St Jude Medical Crmd
- Recall Initiated
- November 28, 2011
- Posted
- January 11, 2012
- Terminated
- May 9, 2012
- Recall Number
- Z-0458-2012
- Quantity
- 128,000 units total
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Riata ST models (700X, 701X, 704X)
Root Cause
Device Design
Action Taken
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.