Recall Z-2147-2014 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
| Date | Aug 5, 2014 (initiated Jun 19, 2014) |
| Status | Terminated |
| Reason | A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Sales representatives hand delivered a Boston Scientific "Medical Device Retrieval" Letter dated June 19, 2014 or June 20, 2014 when they were retrieving the devices from the hospital shelves. The letter was addressed to Hospital Administrator. The letter described the problem, product being recalled and the retrieval of the device by Boston scientific sales representative. For further questions they can contact their local sales representative or Boston Scientific International Technical Services. Physicians were contacted via telephone starting on July 6, 2014. A Boston Scientific lette |
| Quantity | 21 |
| Distribution | Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.