Recall Z-0457-2012 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
St Jude Medical CRMD
St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 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.
| Date | Jan 11, 2012 (initiated Nov 28, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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://s |
| Quantity | 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, Portugal, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, The Netherlands, UK, Australia, Ch |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.