Home / Recalls / Boston Scientific CRM Corp / Z-2147-2014

Z-2147-2014 Class II Terminated

Recalled by Boston Scientific CRM Corp — Saint Paul, MN

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.

Other recalls by Boston Scientific CRM Corp

  • Z-0088-2015 Class II — Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, (September 17, 2014)
  • Z-0087-2015 Class II — Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, (September 17, 2014)
  • Z-0026-2014 Class II — Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, (August 29, 2013)
  • Z-0025-2014 Class II — Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, (August 29, 2013)
  • Z-1979-2013 Class II — Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Card (July 15, 2013)
  • Z-1339-2013 Class II — LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Pa (April 10, 2013)
  • Z-0965-2013 Class II — Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. (March 1, 2013)