St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 70

FDA device recall Z-0458-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

St Jude Medical CRMD

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.

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.

Root cause

Device Design

Status

Terminated

Product code

LWS

Quantity affected

128,000 units total

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

Date initiated

2011-11-28

Date posted

2012-01-11

Date terminated

2012-05-09

Location

Sylmar, CA