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Boston Scientific CRM Corp recalls Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usag
Recalled August 13, 2014 · FDA recall Z-2147-2014 · Boston Scientific CRM
Hazard
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. · FDA Class II
Units
21
Sold at
Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
Description
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.
Product
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.
Manufacturer(s)
Boston Scientific CRM Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →