Z-2147-2014 Class II Terminated
FDA device recall Z-2147-2014 was initiated by Boston Scientific CRM Corp on June 19, 2014 and is designated Class II. Reason for recall: 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 "fail… The recall status is terminated (terminated December 3, 2014). Affected quantity: 21.
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2014
- Initiation Date
- June 19, 2014
- Termination Date
- December 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
Code Information
Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.